45 results on '"Skouby, Sven Olaf"'
Search Results
2. Impact of letrozole co-treatment during ovarian stimulation on oocyte yield, embryo development, and live birth rate in women with normal ovarian reserve:secondary outcomes from the RIOT trial
- Author
-
Bülow, Nathalie Søderhamn, Warzecha, Agnieszka Katarzyna, Nielsen, Mette Villads, Andersen, Claus Yding, Holt, Marianne Dreyer, Petersen, Morten Rønn, Sopa, Negjyp, Zedeler, Anne, Englund, Anne Lis, Pinborg, Anja, Grøndahl, Marie Louise, Skouby, Sven Olaf, Macklon, Nicholas Stephen, Bülow, Nathalie Søderhamn, Warzecha, Agnieszka Katarzyna, Nielsen, Mette Villads, Andersen, Claus Yding, Holt, Marianne Dreyer, Petersen, Morten Rønn, Sopa, Negjyp, Zedeler, Anne, Englund, Anne Lis, Pinborg, Anja, Grøndahl, Marie Louise, Skouby, Sven Olaf, and Macklon, Nicholas Stephen
- Abstract
STUDY QUESTION Does letrozole (LZ) co-treatment during ovarian stimulation with gonadotropins for in IVF impact follicle recruitment, oocyte number and quality, embryo quality, or live birth rate (LBR)? SUMMARY ANSWER No impact of LZ was found in follicle recruitment, number of oocytes, quality of embryos, or LBR. WHAT IS KNOWN ALREADY Multi-follicle stimulation for IVF produces supra-physiological oestradiol levels. LZ is an aromatase inhibitor that lowers serum oestradiol thus reducing negative feedback and increasing the endogenous gonadotropins in both the follicular and the luteal phases, effectively normalizing the endocrine milieu during IVF treatment. STUDY DESIGN, SIZE, DURATION Secondary outcomes from a randomized, double-blind placebo-controlled trial (RCT) investigating once-daily 5 mg LZ or placebo during stimulation for IVF with FSH. The RCT was conducted at four fertility clinics at University Hospitals in Denmark from August 2016 to November 2018 and pregnancy outcomes of frozen-thawed embryo transfers (FET) registered until May 2023. PARTICIPANTS/MATERIALS, SETTING, METHODS One hundred fifty-nine women with expected normal ovarian reserve (anti-Müllerian hormone 8–32 nmol/l) were randomized to either co-treatment with LZ (n = 80) or placebo (n = 79). In total 1268 oocytes were aspirated developing into 386 embryos, and morphology and morphokinetics were assessed. One hundred twenty-nine embryos were transferred in the fresh cycle and 158 embryos in a subsequent FET cycle. The effect of LZ on cumulative clinical pregnancy rate (CPR), LBR, endometrial thickness in the fresh cycle, and total FSH consumption was reported. MAIN RESULTS AND THE ROLE OF CHANCE The proportion of usable embryos of retrieved oocytes was similar in the LZ group and the placebo group with 0.31 vs 0.36 (mean difference (MD) −0.05, 95% CI (−0.12; 0.03), P = 0.65). The size and number of aspirated follicles at oo, STUDY QUESTION: Does letrozole (LZ) co-treatment during ovarian stimulation with gonadotropins for in IVF impact follicle recruitment, oocyte number and quality, embryo quality, or live birth rate (LBR)? SUMMARY ANSWER: No impact of LZ was found in follicle recruitment, number of oocytes, quality of embryos, or LBR. WHAT IS KNOWN ALREADY: Multi-follicle stimulation for IVF produces supra-physiological oestradiol levels. LZ is an aromatase inhibitor that lowers serum oestradiol thus reducing negative feedback and increasing the endogenous gonadotropins in both the follicular and the luteal phases, effectively normalizing the endocrine milieu during IVF treatment. STUDY DESIGN, SIZE, DURATION: Secondary outcomes from a randomized, double-blind placebo-controlled trial (RCT) investigating once-daily 5 mg LZ or placebo during stimulation for IVF with FSH. The RCT was conducted at four fertility clinics at University Hospitals in Denmark from August 2016 to November 2018 and pregnancy outcomes of frozen-thawed embryo transfers (FET) registered until May 2023. PARTICIPANTS/MATERIALS, SETTING, METHODS: One hundred fifty-nine women with expected normal ovarian reserve (anti-Müllerian hormone 8–32 nmol/l) were randomized to either co-treatment with LZ (n = 80) or placebo (n = 79). In total 1268 oocytes were aspirated developing into 386 embryos, and morphology and morphokinetics were assessed. One hundred twenty-nine embryos were transferred in the fresh cycle and 158 embryos in a subsequent FET cycle. The effect of LZ on cumulative clinical pregnancy rate (CPR), LBR, endometrial thickness in the fresh cycle, and total FSH consumption was reported. MAIN RESULTS AND THE ROLE OF CHANCE: The proportion of usable embryos of retrieved oocytes was similar in the LZ group and the placebo group with 0.31 vs 0.36 (mean difference (MD) -0.05, 95% CI (-0.12; 0.03), P = 0.65). The size and number of aspirated follicles at oocyte retrieval were similar with 11.8 vs 10.3 follicles per
- Published
- 2023
3. The Impact of Suppressing Estradiol During Ovarian Stimulation on the Unsupported Luteal Phase: A Randomized Controlled Trial
- Author
-
Dreyer Holt, Marianne, primary, Skouby, Sven Olaf, additional, Bülow, Nathalie Søderhamn, additional, Englund, Anne Lis Mikkelsen, additional, Birch Petersen, Kathrine, additional, and Macklon, Nicholas Stephen, additional
- Published
- 2022
- Full Text
- View/download PDF
4. Does adjuvant letrozole reduce uterine peristalsis prior to fresh embryo transfer?
- Author
-
Holt, Marianne Dreyer, Warzecha, Agnieszka Katarzyna, Bulow, Nathalie Soderhamn, Skouby, Sven Olaf, Englund, Anne Lis Mikkelsen, Petersen, Kathrine Birch, Macklon, Nicholas Stephen, Holt, Marianne Dreyer, Warzecha, Agnieszka Katarzyna, Bulow, Nathalie Soderhamn, Skouby, Sven Olaf, Englund, Anne Lis Mikkelsen, Petersen, Kathrine Birch, and Macklon, Nicholas Stephen
- Abstract
STUDY QUESTION Does adjuvant letrozole in ovarian stimulation for IVF decrease the uterine peristalsis frequency (UPF) prior to fresh embryo transfer (ET)? SUMMARY ANSWER Adjuvant letrozole in ovarian stimulation for IVF does not reduce the UPF significantly prior to fresh ET. WHAT IS KNOWN ALREADY Throughout the cycle, uterine peristalsis aids spermatozoa transport to the fallopian tube and may affect implantation. At fresh ET, UPF is negatively correlated with implantation and clinical pregnancy rates and is believed to be modulated by oestradiol and progesterone. High levels of oestradiol, from multiple follicular development, in ovarian stimulation have been reported to increase UPF, whereas progesterone is considered to be an utero-relaxant. The influence of androgens is unclear. Co-treatment with letrozole during gonadotropin ovarian stimulation limits the supra-physiological oestradiol rise and may therefore reduce UPF prior to fresh ET. STUDY DESIGN, SIZE, DURATION This study was carried out on subjects participating in a single-centre double-blinded randomized controlled trial of the impact of letrozole on follicle development and endocrine profiles, and investigated the impact of adjuvant letrozole in ovarian stimulation for IVF on UPF prior to fresh ET and the correlations of UPF with endocrine markers. Between 2016 and 2017, 39 women expected to be normal responders were randomized to co-treatment with letrozole or placebo. Of these, 33 women completed this element of the study. The study was carried out according to the Helsinki Declaration and the ICH-Good-Clinical-Practice. PARTICIPANTS/MATERIALS, SETTING, METHODS Eligible women were randomized 1:1 to adjuvant treatment with letrozole 5 mg/day or placebo in an antagonist protocol using a fixed dose of recombinant (r) FSH 150 IU/day. Final maturation was triggered with hCG 6500 IU and luteal support with vaginal progesterone was administered from the day following oocyte aspiration. Less than 1 h pr
- Published
- 2022
5. The Impact of Suppressing Estradiol During Ovarian Stimulation on the Unsupported Luteal Phase:A Randomized Controlled Trial
- Author
-
Dreyer Holt, Marianne, Skouby, Sven Olaf, Bulow, Nathalie Soderhamn, Englund, Anne Lis Mikkelsen, Birch Petersen, Kathrine, Macklon, Nicholas Stephen, Dreyer Holt, Marianne, Skouby, Sven Olaf, Bulow, Nathalie Soderhamn, Englund, Anne Lis Mikkelsen, Birch Petersen, Kathrine, and Macklon, Nicholas Stephen
- Abstract
Context Supraphysiological sex steroid levels at the follicular-luteal phase transition are implicated as the primary cause of luteal insufficiency after ovarian stimulation (OS) for in vitro fertilization. Objective We aimed to determine the impact of suppressing estradiol levels during OS of multiple dominant follicles on the unsupported luteal phase and markers of endometrial maturation. Methods At 2 university hospitals, 25 eligible egg donors were randomized to undergo OS using exogenous gonadotropins with or without adjuvant letrozole 5 mg/day. Final oocyte maturation was triggered with a GnRH agonist. No luteal support was provided. The primary outcome was the duration of the luteal phase. Secondary outcomes were luteal phase hormone profiles and the endometrial transcriptomic signature 5 days after oocyte pick up (OPU + 5). Results The median (interquartile range [IQR]) luteal phase duration was 8.0 (6.8-11.5) days compared with 5.0 (5.0-6.8) days in the intervention and control group, respectively (P < 0.001). Estradiol levels were effectively suppressed in the letrozole group with a median of 0.86 (0.23-1.24) nmol/L at OPU compared to 2.82 (1.34-3.44) nmol/L in the control group. Median (IQR) progesterone levels at OPU + 5 were 67.05 (15.67-101.75) nmol/L in the letrozole group vs 2.27 (1.05-10.70) nmol/L in the control group (P < 0.001). In the letrozole group, 75% of participants revealed endometrial transcriptomic signatures interpreted as post-receptive. In the control group, 40% were post-receptive and 50% noninformative. Conclusion Suppressing estradiol levels in the follicular phase with adjuvant letrozole significantly reduces the disruption of the unsupported luteal phase after OS.
- Published
- 2022
6. Impact of letrozole co-treatment during ovarian stimulation with gonadotrophins for IVF:a multicentre, randomized, double-blinded placebo-controlled trial
- Author
-
Bülow, Nathalie Søderhamn, Skouby, Sven Olaf, Warzecha, Agnieszka Katarzyna, Udengaard, Hanne, Andersen, Claus Yding, Holt, Marianne Dreyer, Grøndahl, Marie Louise, Nyboe Andersen, Anders, Sopa, Negjyp, Mikkelsen, Anne Lis Englund, Pinborg, Anja, Macklon, Nicholas Stephen, Bülow, Nathalie Søderhamn, Skouby, Sven Olaf, Warzecha, Agnieszka Katarzyna, Udengaard, Hanne, Andersen, Claus Yding, Holt, Marianne Dreyer, Grøndahl, Marie Louise, Nyboe Andersen, Anders, Sopa, Negjyp, Mikkelsen, Anne Lis Englund, Pinborg, Anja, and Macklon, Nicholas Stephen
- Abstract
Study Question: Does letrozole co-treatment during ovarian stimulation with gonadotrophins for IVF reduce the proportion of women with premature progesterone levels above 1.5 ng/ml at the time of triggering final oocyte maturation? Summary Answer: The proportion of women with premature progesterone above 1.5 ng/ml was not significantly affected by letrozole co-treatment. WHAT IS KNOWN ALREADY: IVF creates multiple follicles with supraphysiological levels of sex steroids interrupting the endocrine milieu and affects the window of implantation. Letrozole is an effective aromatase inhibitor, normalizing serum oestradiol, thereby ameliorating some of the detrimental effects of IVF treatment. STUDY DESIGN, SIZE, DURATION: A randomized, double-blinded placebo-controlled trial investigated letrozole intervention during stimulation for IVF with FSH. The trial was conducted at four fertility clinics at University Hospitals in Denmark from August 2016 to November 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS: A cohort of 129 women with expected normal ovarian reserve (anti-Müllerian hormone 8-32 nmol/l) completed an IVF cycle with fresh embryo transfer and received co-treatment with either 5 mg/day letrozole (n = 67) or placebo (n = 62), along with the FSH. Progesterone, oestradiol, FSH, LH and androgens were analysed in repeated serum samples collected from the start of the stimulation to the mid-luteal phase. In addition, the effect of letrozole on reproductive outcomes, total FSH consumption and adverse events were assessed. MAIN RESULTS AND THE ROLE OF CHANCE: The proportion of women with premature progesterone >1.5 ng/ml was similar (6% vs 0% (OR 0.0, 95% CI [0.0; 1.6], P = 0.12) in the letrozole versus placebo groups, respectively), whereas the proportion of women with mid-luteal progesterone >30 ng/ml was significantly increased in the letrozole group: (59% vs 31% (OR 3.3, 95% CI [1.4; 7.1], P = 0.005)). Letrozole versus placebo decreased oestradiol levels on
- Published
- 2022
7. Co-treatment with letrozole during ovarian stimulation for IVF/ICSI:a systematic review and meta-analysis
- Author
-
Bülow, Nathalie Søderhamn, Dreyer Holt, Marianne, Skouby, Sven Olaf, Birch Petersen, Kathrine, Englund, Anne Lis Mikkelsen, Pinborg, Anja, Macklon, Nicholas Stephen, Bülow, Nathalie Søderhamn, Dreyer Holt, Marianne, Skouby, Sven Olaf, Birch Petersen, Kathrine, Englund, Anne Lis Mikkelsen, Pinborg, Anja, and Macklon, Nicholas Stephen
- Abstract
Letrozole reduces serum oestradiol by inhibiting the aromatase enzyme and has growing clinical indications in fertility. The available evidence of letrozole's role in ovarian stimulation for IVF and intracytoplasmic sperm injection (ICSI) and clinical outcomes was assessed. Medline, Cochrane, and ClinicalTrials.gov databases were systematically searched up until August 2021, including 31 studies (n = 16 randomized controlled trials [RCTs]; n = 15 observational studies). Live birth rate (LBR) in poor responders significantly increased by 7% (95% CI, 1% to 13%, P = 0.03) with letrozole co-treatment. Concomitantly, the gonadotrophin consumption was significantly reduced, without decreasing the number of retrieved oocytes. In normal responders, number of oocytes increased with 1.8 oocytes (95% CI 0.35 to 3.27, P = 0.01) with letrozole co-treatment. No significant effect on LBR, clinical pregnancy rate (CPR), or ovarian hyperstimulation syndrome rate was demonstrated. Only two studies reported on high responders and revealed no effect on LBR or CPR. Overall, the endometrium thickness was slightly affected, where as the, miscarriage rate and cancellation rate were unaffected by letrozole co-treatment. None of the included studies reported on neonatal outcomes. The quality of evidence was high or moderate in the RCTs and low in the observational studies. In conclusion, poor responders may benefit from co-treatment with letrozole during ovarian stimulation for IVF, whereas letrozole for normal and high responders requires further investigation with larger, high-quality studies.
- Published
- 2022
8. Semen Quality as a Predictor of Subsequent Morbidity: A Danish Cohort Study of 4,712 Men With Long-Term Follow-up
- Author
-
Latif, Tabassam, Kold Jensen, Tina, Mehlsen, Jesper, Holmboe, Stine Agergaard, Brinth, Louise, Pors, Kirsten, Skouby, Sven Olaf, Jørgensen, Niels, and Lindahl-Jacobsen, Rune
- Published
- 2017
- Full Text
- View/download PDF
9. Co-treatment with letrozole during ovarian stimulation for IVF/ICSI: a systematic review and meta-analysis
- Author
-
Bülow, Nathalie Søderhamn, primary, Dreyer Holt, Marianne, additional, Skouby, Sven Olaf, additional, Birch Petersen, Kathrine, additional, Englund, Anne Lis Mikkelsen, additional, Pinborg, Anja, additional, and Macklon, Nicholas Stephen, additional
- Published
- 2022
- Full Text
- View/download PDF
10. Impact of letrozole co-treatment during ovarian stimulation with gonadotrophins for IVF: a multicentre, randomized, double-blinded placebo-controlled trial
- Author
-
Bülow, Nathalie Søderhamn, primary, Skouby, Sven Olaf, additional, Warzecha, Agnieszka Katarzyna, additional, Udengaard, Hanne, additional, Andersen, Claus Yding, additional, Holt, Marianne Dreyer, additional, Grøndahl, Marie Louise, additional, Nyboe Andersen, Anders, additional, Sopa, Negjyp, additional, Mikkelsen, Anne Lis Englund, additional, Pinborg, Anja, additional, and Macklon, Nicholas Stephen, additional
- Published
- 2021
- Full Text
- View/download PDF
11. DOES ADJUVANT LETROZOLE DURING OVARIAN STIMULATION FOR IVF REDUCE THE NEED FOR LUTEAL SUPPORT? A RANDOMIZED CONTROLLED TRIAL
- Author
-
Holt, Marianne Dreyer, primary, Skouby, Sven Olaf, additional, Warzecha, Agnieszka, additional, Bülow, Nathalie Søderhamn, additional, Englund Mikkelsen, Anne Lis, additional, Petersen, Kathrine Birch, additional, and Macklon, Nick, additional
- Published
- 2021
- Full Text
- View/download PDF
12. The Impact of Suppressing Estradiol During Ovarian Stimulation on the Unsupported Luteal Phase: A Randomized Controlled Trial.
- Author
-
Holt, Marianne Dreyer, Skouby, Sven Olaf, Bülow, Nathalie Søderhamn, Mikkelsen Englund, Anne Lis, Petersen, Kathrine Birch, and Macklon, Nicholas Stephen
- Subjects
SEX hormones ,INDUCED ovulation ,ESTRADIOL - Abstract
Context: Supraphysiological sex steroid levels at the follicular-luteal phase transition are implicated as the primary cause of luteal insufficiency after ovarian stimulation (OS) for in vitro fertilization. Objective: We aimed to determine the impact of suppressing estradiol levels during OS of multiple dominant follicles on the unsupported luteal phase and markers of endometrial maturation. Methods: At 2 university hospitals, 25 eligible egg donors were randomized to undergo OS using exogenous gonadotropins with or without adjuvant letrozole 5 mg/day. Final oocyte maturation was triggered with a GnRH agonist. No luteal support was provided. The primary outcome was the duration of the luteal phase. Secondary outcomes were luteal phase hormone profiles and the endometrial transcriptomic signature 5 days after oocyte pick up (OPU + 5). Results: The median (interquartile range [IQR]) luteal phase duration was 8.0 (6.8-11.5) days compared with 5.0 (5.0-6.8) days in the intervention and control group, respectively (P < 0.001). Estradiol levels were effectively suppressed in the letrozole group with a median of 0.86 (0.23-1.24) nmol/L at OPU compared to 2.82 (1.34-3.44) nmol/L in the control group. Median (IQR) progesterone levels at OPU + 5 were 67.05 (15.67-101.75) nmol/L in the letrozole group vs 2.27 (1.05-10.70) nmol/L in the control group (P < 0.001). In the letrozole group, 75% of participants revealed endometrial transcriptomic signatures interpreted as post-receptive. In the control group, 40% were post-receptive and 50% noninformative. Conclusion: Suppressing estradiol levels in the follicular phase with adjuvant letrozole significantly reduces the disruption of the unsupported luteal phase after OS. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
13. Oestrogen-free oral contraception with a 4 micrograms drospirenone-only pill: new data and a review of the literature
- Author
-
Palacios, Santiago, Regidor, Pedro-Antonio, Colli, Enrico, Skouby, Sven Olaf, Apter, Dan, Roemer, Thomas, Egarter, Christian, Nappi, Rossella E., Skrivanek, Ales, Jakimiuk, Artur J., Weyers, Steven, Acs, Nandor, Elia, David, Gemzell Danielsson, Kristina, Bitzer, Johannes, Palacios, Santiago, Regidor, Pedro-Antonio, Colli, Enrico, Skouby, Sven Olaf, Apter, Dan, Roemer, Thomas, Egarter, Christian, Nappi, Rossella E., Skrivanek, Ales, Jakimiuk, Artur J., Weyers, Steven, Acs, Nandor, Elia, David, Gemzell Danielsson, Kristina, and Bitzer, Johannes
- Abstract
Purpose: The contraceptive pill is an effective and safe method of preventing pregnancy. The progestins used for contraception either are components of a combined hormonal contraceptive (tablets, patches or vaginal rings) or are used alone in progestin-only formulations. Progestin-only contraceptives are available as daily oral preparations, subcutaneous or intramuscular injectables (every 1-3 months), subdermal implants (every 3-5 years) and intrauterine systems (every 3-5 years). Long-acting progestins are highly effective in typical use and have a very low risk profile and few contraindications. Material and Methods: A new progestin-only, oestrogen-free contraceptive, drospirenone, in a dosage of 4 mg/day in a 24/4 regimen, has received regulatory approval in the USA and the EU. The molecule has antigonadotropic, antimineralocorticoid, antiestrogenic and antiandrogenic properties. Results: The regimen was chosen to improve the bleeding profile; maintain plasma oestradiol levels at those of the early follicular phase, to avoid hypoestrogenism; and preserve efficacy even with a missed pill, as drospirenone has a half-life of 30-34 h. Conclusions: Clinical studies have shown good efficacy, very low cardiovascular side effects and a favourable bleeding pattern, as well as maintenance of ovulation inhibition after scheduled 24 h delays in pill intake.
- Published
- 2020
14. Oestrogen-free oral contraception with a 4 mg drospirenone-only pill:new data and a review of the literature
- Author
-
Palacios, Santiago, Regidor, Pedro Antonio, Colli, Enrico, Skouby, Sven Olaf, Apter, Dan, Roemer, Thomas, Egarter, Christian, Nappi, Rossella E., Skřivánek, Aleš, Jakimiuk, Artur J., Weyers, Steven, Ács, Nándor, Elia, David, Gemzell Danielsson, Kristina, Bitzer, Johannes, Palacios, Santiago, Regidor, Pedro Antonio, Colli, Enrico, Skouby, Sven Olaf, Apter, Dan, Roemer, Thomas, Egarter, Christian, Nappi, Rossella E., Skřivánek, Aleš, Jakimiuk, Artur J., Weyers, Steven, Ács, Nándor, Elia, David, Gemzell Danielsson, Kristina, and Bitzer, Johannes
- Abstract
Purpose: The contraceptive pill is an effective and safe method of preventing pregnancy. The progestins used for contraception either are components of a combined hormonal contraceptive (tablets, patches or vaginal rings) or are used alone in progestin-only formulations. Progestin-only contraceptives are available as daily oral preparations, subcutaneous or intramuscular injectables (every 1–3 months), subdermal implants (every 3–5 years) and intrauterine systems (every 3–5 years). Long-acting progestins are highly effective in typical use and have a very low risk profile and few contraindications. Material and Methods: A new progestin-only, oestrogen-free contraceptive, drospirenone, in a dosage of 4 mg/day in a 24/4 regimen, has received regulatory approval in the USA and the EU. The molecule has antigonadotropic, antimineralocorticoid, antiestrogenic and antiandrogenic properties. Results: The regimen was chosen to improve the bleeding profile; maintain plasma oestradiol levels at those of the early follicular phase, to avoid hypoestrogenism; and preserve efficacy even with a missed pill, as drospirenone has a half-life of 30–34 h. Conclusions: Clinical studies have shown good efficacy, very low cardiovascular side effects and a favourable bleeding pattern, as well as maintenance of ovulation inhibition after scheduled 24 h delays in pill intake.
- Published
- 2020
15. Impact of letrozole co-treatment during ovarian stimulation with gonadotrophins for IVF: a multicentre, randomized, double-blinded placebo-controlled trial.
- Author
-
Bülow, Nathalie Søderhamn, Skouby, Sven Olaf, Warzecha, Agnieszka Katarzyna, Udengaard, Hanne, Andersen, Claus Yding, Holt, Marianne Dreyer, Grøndahl, Marie Louise, Andersen, Anders Nyboe, Sopa, Negjyp, Mikkelsen, Anne Lis Englund, Pinborg, Anja, Macklon, Nicholas Stephen, and Nyboe Andersen, Anders
- Subjects
- *
INDUCED ovulation , *FROZEN human embryos , *OVARIAN reserve , *HUMAN in vitro fertilization , *LETROZOLE , *FERTILIZATION in vitro , *LUTEAL phase , *RESEARCH , *PROGESTERONE , *FOLLICLE-stimulating hormone , *CLINICAL trials , *BIRTH rate , *ESTRADIOL , *ANDROGENS , *GONADOTROPIN , *RESEARCH funding - Abstract
Study Question: Does letrozole co-treatment during ovarian stimulation with gonadotrophins for IVF reduce the proportion of women with premature progesterone levels above 1.5 ng/ml at the time of triggering final oocyte maturation?Summary Answer: The proportion of women with premature progesterone above 1.5 ng/ml was not significantly affected by letrozole co-treatment.What Is Known Already: IVF creates multiple follicles with supraphysiological levels of sex steroids interrupting the endocrine milieu and affects the window of implantation. Letrozole is an effective aromatase inhibitor, normalizing serum oestradiol, thereby ameliorating some of the detrimental effects of IVF treatment.Study Design, Size, Duration: A randomized, double-blinded placebo-controlled trial investigated letrozole intervention during stimulation for IVF with FSH. The trial was conducted at four fertility clinics at University Hospitals in Denmark from August 2016 to November 2018.Participants/materials, Setting, Methods: A cohort of 129 women with expected normal ovarian reserve (anti-Müllerian hormone 8-32 nmol/l) completed an IVF cycle with fresh embryo transfer and received co-treatment with either 5 mg/day letrozole (n = 67) or placebo (n = 62), along with the FSH. Progesterone, oestradiol, FSH, LH and androgens were analysed in repeated serum samples collected from the start of the stimulation to the mid-luteal phase. In addition, the effect of letrozole on reproductive outcomes, total FSH consumption and adverse events were assessed.Main Results and the Role Of Chance: The proportion of women with premature progesterone >1.5 ng/ml was similar (6% vs 0% (OR 0.0, 95% CI [0.0; 1.6], P = 0.12) in the letrozole versus placebo groups, respectively), whereas the proportion of women with mid-luteal progesterone >30 ng/ml was significantly increased in the letrozole group: (59% vs 31% (OR 3.3, 95% CI [1.4; 7.1], P = 0.005)). Letrozole versus placebo decreased oestradiol levels on the ovulation trigger day by 68% (95% CI [60%; 75%], P < 0.0001). Other hormonal profiles, measured as AUC, showed the following results. The increase in LH in the letrozole group versus placebo group was 38% (95% CI [21%; 58%], P < 0.0001) and 34% (95% CI [11%; 61%], P = 0.006) in the follicular and luteal phases, respectively. In the letrozole group versus placebo group, testosterone increased by 79% (95% CI [55%; 105%], P < 0.0001) and 49% (95% CI [30%; 72%], P < 0.0001) in the follicular and luteal phases, respectively. In the letrozole group versus placebo group, the increase in androstenedione was by 85% (95% CI [59%; 114%], P < 0.0001) and 69% (95% CI [48%; 94%], P < 0.0001) in the follicular and luteal phases, respectively. The ongoing pregnancy rate was similar between the letrozole and placebo groups (31% vs 39% (risk-difference of 8%, 95% CI [-25%; 11%], P = 0.55)). No serious adverse reactions were recorded in either group. The total duration of exogenous FSH stimulation was 1 day shorter in the intervention group, significantly reducing total FSH consumption (mean difference -100 IU, 95% CI [-192; -21], P = 0.03).Limitations, Reasons For Caution: Late follicular progesterone samples were collected on the day before and day of ovulation triggering for patient logistic considerations, and the recently emerged knowledge about diurnal variation of progesterone was not taken into account. The study was powered to detect hormonal variations but not differences in pregnancy outcomes.Wider Implications Of the Findings: Although the use of letrozole has no effect on the primary outcome, the number of women with a premature increase in progesterone on the day of ovulation triggering, the increased progesterone in the mid-luteal phase due to letrozole may contribute to optimizing the luteal phase endocrinology. The effect of letrozole on increasing androgens and reducing FSH consumption may be used in poor responders. However, the effect of letrozole on implantation and ongoing pregnancy rates should be evaluated in a meta-analysis or larger randomized controlled trial (RCT).Study Funding/competing Interest(s): Funding was received from EU Interreg for ReproUnion and Ferring Pharmaceuticals, and Roche Diagnostics contributed with assays. N.S.M. and A.P. have received grants from Ferring, Merck Serono, Anecova and Gedeon Richter, and/or personal fees from IBSA, Vivoplex, ArtPred and SPD, outside the submitted work. The remaining authors have no competing interests.Trial Registration Numbers: NCT02939898 and NCT02946684.Trial Registration Date: 15 August 2016.Date Of First Patient’s Enrolment: 22 August 2016. [ABSTRACT FROM AUTHOR]- Published
- 2022
- Full Text
- View/download PDF
16. Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature
- Author
-
Palacios, Santiago, primary, Regidor, Pedro-Antonio, additional, Colli, Enrico, additional, Skouby, Sven Olaf, additional, Apter, Dan, additional, Roemer, Thomas, additional, Egarter, Christian, additional, Nappi, Rossella E., additional, Skřivánek, Aleš, additional, Jakimiuk, Artur J., additional, Weyers, Steven, additional, Ács, Nándor, additional, Elia, David, additional, Gemzell Danielsson, Kristina, additional, and Bitzer, Johannes, additional
- Published
- 2020
- Full Text
- View/download PDF
17. Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial
- Author
-
Saupstad, Marte, primary, Freiesleben, Nina La Cour, additional, Skouby, Sven Olaf, additional, Andersen, Lars Franch, additional, Knudsen, Ulla Breth, additional, Petersen, Kathrine Birch, additional, Husth, Merete, additional, Egeberg, Anne, additional, Petersen, Morten Rønn, additional, Ziebe, Søren, additional, Andersen, Anders Nyboe, additional, Løssl, Kristine, additional, and Pinborg, Anja, additional
- Published
- 2019
- Full Text
- View/download PDF
18. Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET):A study protocol for a randomised controlled multicentre trial
- Author
-
Saupstad, Marte, Freiesleben, Nina La Cour, Skouby, Sven Olaf, Andersen, Lars Franch, Knudsen, Ulla Breth, Petersen, Kathrine Birch, Husth, Merete, Egeberg, Anne, Petersen, Morten Rønn, Ziebe, Søren, Andersen, Anders Nyboe, Løssl, Kristine, Pinborg, Anja, Saupstad, Marte, Freiesleben, Nina La Cour, Skouby, Sven Olaf, Andersen, Lars Franch, Knudsen, Ulla Breth, Petersen, Kathrine Birch, Husth, Merete, Egeberg, Anne, Petersen, Morten Rønn, Ziebe, Søren, Andersen, Anders Nyboe, Løssl, Kristine, and Pinborg, Anja
- Abstract
Introduction Despite the high number of frozen embryo transfer (FET) cycles being conducted (190 000 cycles/year) in Europe, the timing of blastocyst transfer and the use of luteal phase progesterone support in modified natural cycle FET (mNC-FET) in assisted reproductive technologies are controversial. In mNC-FET, the timing of blastocyst warming and transfer is determined according to the time of implantation in a natural cycle, aiming to reach blastocyst endometrial synchronicity. However, the optimal day of blastocyst transfer following ovulation trigger is not determined. In addition, the value of luteal phase support to maintain the endometrium remains uncertain. Thus, there is a need to identify the optimal timing of blastocyst warming and transfer and the effect of luteal phase support in a randomised controlled trial design. The aim of this randomised controlled trial is to investigate if progesterone supplementation from the early luteal phase until gestational age 8 weeks is superior to no progesterone supplementation and to assess if blastocyst warming and transfer 6 days after ovulation trigger is superior to 7 days after ovulation trigger in mNC-FET with live birth rates as the primary outcome. Methods and analysis Multicentre, randomised, controlled, single-blinded trial including 604 normo-ovulatory women aged 18-41 years undergoing mNC-FET with a high-quality blastocyst originating from their first to third in vitro fertilisation/intracytoplasmic sperm injection cycle. Participants are randomised (1:1:1:1) to either luteal phase progesterone or no luteal phase progesterone and to blastocyst warming and transfer on day 6 or 7 after human chorionic gonadotropin trigger. Only single blastocyst transfers will be performed. Ethics and dissemination The study is approved by the Danish Committee on Health Research Ethics (H-18025839), the Danish Medicines Agency (2018061319) and the Danish Data Protection Agency (VD-2018-381). The results of the study w
- Published
- 2019
19. The impact of the biological variability or assay performance on AMH measurements:A prospective cohort study with AMH tested on three analytical assay-platforms
- Author
-
Bungum, Leif, Tagevi, Julia, Jokubkiene, Ligita, Bungum, Mona, Giwercman, Aleksander, Macklon, Nick, Andersen, Claus Yding, Klausen, Tobias Wirenfeldt, Tørring, Niels, Kumar, Ajay, Skouby, Sven Olaf, Bungum, Leif, Tagevi, Julia, Jokubkiene, Ligita, Bungum, Mona, Giwercman, Aleksander, Macklon, Nick, Andersen, Claus Yding, Klausen, Tobias Wirenfeldt, Tørring, Niels, Kumar, Ajay, and Skouby, Sven Olaf
- Abstract
This study examined longitudinal, age-related and intra-individual variation in Anti-Müllerian Hormone (AMH) in regular menstruating women and correlated the hormonal levels to the antral follicle count (AFC). The impact of variations on an algorithm for calculation of follitropin-dose for ovarian stimulation were also tested. The study was carried out at a fertility clinic of a tertiary university hospital and had a prospective trial design. Twenty-six healthy women not receiving infertility treatment aged 22 to 50 years participated. Blood sampling for hormonal analysis was done every fifth day throughout three consecutive menstrual cycles, AFC was determined with 3-dimentional ultrasound and AMH measured by different assays from Beckman Coulter, Roche and Ansh Labs. Outcome measures were maximum and minimum difference in absolute and relative terms for each study subject during the test-period, coefficient of variation (Cv) for AMH for each cycle and cycle-day and correlation between AMH and AFC. The impact from variable AMH levels on an algorithm calculating follitrophin-delta dose in ovarian stimulation was explored. A significant longitudinal age-independent variation in AMH-levels and coefficient of variation in cycles and cycle days was found. A strong correlation between AMH-levels and AFC was confirmed and a case of significant divergence between assays was seen. Variations in AMH had a significant impact on an algorithm calculated dosage of gonadotrophins in ovarian stimulation. The finding of a substantial longitudinal variation in AMH question one recording being sufficient in quantifying gonadotrophins for ovarian stimulation, decision making and prognostication related to infertility treatment and counseling. Occasionally, commercial assays may fail to recognize specific AMH cleavage-products.
- Published
- 2018
20. Effects of Contraceptive Steroids on Cardiovascular Risk Factors in Women With Insulin-Dependent Diabetes Mellitus
- Author
-
Petersen, Kresten Rubeck, Skouby, Sven Olaf, Sidelmann, Johannes, Molsted-Pedersen, Lars, and Jespersen, Jorgen
- Published
- 1994
21. The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-Platforms
- Author
-
Bungum, Leif, primary, Tagevi, Julia, additional, Jokubkiene, Ligita, additional, Bungum, Mona, additional, Giwercman, Aleksander, additional, Macklon, Nick, additional, Andersen, Claus Yding, additional, Klausen, Tobias Wirenfeldt, additional, Tørring, Niels, additional, Kumar, Ajay, additional, and Skouby, Sven Olaf, additional
- Published
- 2018
- Full Text
- View/download PDF
22. Semen Quality as a Predictor of Subsequent Morbidity:A Danish Cohort Study of 4,712 Men with Long-Term Follow-up
- Author
-
Latif, Tabassam, Jensen, Tina Kold, Mehlsen, Jesper, Holmboe, Stine Agergaard, Brinth, Louise, Skouby, Sven Olaf, Jørgensen, Niels, Lindahl-Jacobsen, Rune, Latif, Tabassam, Jensen, Tina Kold, Mehlsen, Jesper, Holmboe, Stine Agergaard, Brinth, Louise, Skouby, Sven Olaf, Jørgensen, Niels, and Lindahl-Jacobsen, Rune
- Abstract
Semen quality has been suggested to be a biologicalmarker of long-term morbidity and mortality; however, few studies have been conducted on this subject. We identified 5,370 men seen for infertility at Frederiksberg Hospital, Denmark, during 1977-2010, and 4,712 of thesemen were followed in the Danish National Patient Registry until first hospitalization, death, or the end of the study.We classified patients according to hospitalizations and the presence of cardiovascular disease, diabetes, testicular cancer, or prostate cancer. We found a clear association between sperm concentration below 15million/mL and all-cause hospitalizations (hazard ratio = 1.5, 95% confidence interval: 1.4, 1.6) and cardiovascular disease (hazard ratio = 1.4, 95% confidence interval: 1.2, 1.6), compared with men with a concentration above 40million/ mL. The probabilities for hospitalizations were also higher with a low total sperm count and low motility. Men with a sperm concentration of 195-200million/mL were, on average, hospitalized for the first time 7 years later than were men with a sperm concentration of 0-5million/mL. Semen quality was associated with long-term morbidity, and a significantly higher risk of hospitalization was found, in particular for cardiovascular diseases and diabetes mellitus. Our study supports the suggestion that semen quality is a strong biomarker of general health.
- Published
- 2017
23. Venous thromboembolism in women: a specific reproductive health risk
- Author
-
Group, ESHRE Capri Workshop, Skouby, Sven Olaf, Group, ESHRE Capri Workshop, and Skouby, Sven Olaf
- Published
- 2013
24. Betydningen af PCOS og overvægt for svangerskabs- og fødselskomplikationer efter fertilitetsbehandling
- Author
-
Naver, Klara, Nilas, Lisbeth, Jørgensen, Finn Stener, Skouby, Sven Olaf, Aziz, mubeena, Mikkelsen, Anne Lis, Wissing, Marie Louise, Naver, Klara, Nilas, Lisbeth, Jørgensen, Finn Stener, Skouby, Sven Olaf, Aziz, mubeena, Mikkelsen, Anne Lis, and Wissing, Marie Louise
- Abstract
Et klinisk prospektivt multicenterstudie. Projektet består af prægravid karakteristik af kvinder med og uden polycystisk ovariesyndrom (PCOS) før de opstarter fertilitetsbehandling. Når deltagerne er blevet gravide følges de i graviditeten med ultralydskanninger og målinger af insulin resistens, metaboliske og inflammatoriske markører.
- Published
- 2013
25. A prospective randomized multicentre study comparing vaginal progesterone gel and vaginal micronized progesterone tablets for luteal support after in vitro fertilization/intracytoplasmic sperm injection
- Author
-
Bergh, Christina, Lindenberg, Svend, Skouby, Sven Olaf, Bergh, Christina, Lindenberg, Svend, and Skouby, Sven Olaf
- Abstract
SUMMARY QUESTION: Is vaginal progesterone gel equivalent to vaginal micronized progesterone tablets concerning ongoing pregnancy rate and superior concerning patient convenience when used for luteal support after IVF/ICSI? SUMMARY ANSWER: Equivalence of treatments in terms of ongoing live intrauterine pregnancy rate has not been demonstrated; the 95% confidence interval (CI) for the difference in ongoing pregnancy rate (-8.2 to 0.1%) did not lie entirely within the pre-specified equivalence interval -7 to 7%. WHAT IS KNOWN ALREADY: No significant differences in clinical pregnancy rates have been observed between vaginal progesterone gel and other vaginal progesterone products in earlier studies. However, all previous studies included a limited number of patients. STUDY DESIGN, SIZE AND DURATION: This was a randomized, multicentre, controlled, assessor-blinded equivalence trial in 18 fertility centres in Denmark and Sweden between March 2006 and January 2010. A web-based randomization program was used with concealed allocation of patients. Patients were randomized to one of two groups: vaginal progesterone gel or vaginal micronized progesterone tablets. There was no blinding of patients. PARTICIPANTS AND SETTING: A total of 2057 women ≤ 40 years of age were included and down-regulated, using the long agonist protocol and rFSH for stimulation. Luteal support was given for 19 days after embryo transfer or until a negative pregnancy test Day 14 after embryo transfer. Patient convenience was assessed using questionnaires to be filled in 14 days after embryo transfer, before pregnancy test. MAIN RESULTS AND THE ROLE OF CHANCE: Ongoing intrauterine pregnancy rates were 299/991 (30.2%) (95% CI 27.3-33.0%) in the progesterone gel group and 324/992 (32.7%) (29.7-35.6%) in the micronized progesterone tablet group. The difference in ongoing pregnancy rates between the groups was -4.1% (-8.2 to 0.1%) and the difference in live birth rates was -3.4% (-7.4 to 0.7%), both calculate
- Published
- 2012
26. Polycystic ovary syndrome:infertility, cardiovascular, metabolic and obstetrical risks, laboratory and clinical outcomes-The PICOLO Study
- Author
-
Aziz, M, Naver, Klara, Wissing, Marie Louise Muff, Mikkelsen, Aage, Nilas, L, Skouby, Sven Olaf, Aziz, M, Naver, Klara, Wissing, Marie Louise Muff, Mikkelsen, Aage, Nilas, L, and Skouby, Sven Olaf
- Abstract
Objectives: The primary objective of this multicenter study is to evaluate the relative impact of insulin resistance (IR) and body mass index (BMI) in women with polycystic ovary syndrome (PCOS) on (1) Key hemodynamic/thrombogenic variables, (2) Oocyte quality and early embryo development, (3) Fetal growth, placental function and adverse obstetric outcome. Secondary objective: To establish a PCOS database and biobank facilitating future basic and interventional research related to PCOS. Design: A cross-sectional and longitudinal cohort study at four University Hospitals in Denmark. Population inclusion: About 200 women fulfilling the Rotterdam Criteria and 100 women without PCOS recruited from 2010 to 2012. Methods: The impact of PCOS, as well as the impact of IR and BMI on the hormonal, metabolic and hemostatic key variables will be analyzed combining conventional, molecular techniques and selected gene analysis. Oocytes will be characterized by gene expression of granulosa and cumulus cells and the early embryo development will be followed by time lapse microscopy. Fetal growth will be assessed by repeated ultrasound measurements, and the pregnancy outcome compared to maternal and fetal biochemical markers of growth and inflammation and clinical pregnancy complications. Main outcome measures: Metabolic and hemostatic risk-biomarkers, oocyte and embryo quality, adverse pregnancy outcome, fetal growth and placental function in women with PCOS.
- Published
- 2012
27. Gynækologi: Dysmenoré
- Author
-
Skouby, Sven Olaf and Skouby, Sven Olaf
- Published
- 2011
28. Gynækologi: Klimakteriet og menopausen, Ch. 16, p. 267-279
- Author
-
Skouby, Sven Olaf and Skouby, Sven Olaf
- Published
- 2011
29. Risiko for øget sygelighed hos kvindelige idraetsudøvere
- Author
-
Olesen, Anette Grønning, Clausen, Helle Vibeke, Skouby, Sven Olaf, Ottsen, Anna, Peen, Anette, Olesen, Anette Grønning, Clausen, Helle Vibeke, Skouby, Sven Olaf, Ottsen, Anna, and Peen, Anette
- Abstract
The female athlete triad refers to the interrelationships among energy availability, menstrual function and bone mineral density which may have clinical manifestations including eating disorders, functional hypothalamic amenorrhea and osteoporosis. The potentially irreversible consequences of these clinical conditions emphasize the critical need for prevention, early diagnosis and treatment. Nutritionally correct food ensuring optimal energy balance is a premise to improve these conditions. Alternative treatment is oestrogen replacement therapy which can prevent progressive bone loss.
- Published
- 2010
30. Validation of spontaneous abortion diagnoses in the Danish National Registry of Patients
- Author
-
Lohse, Sarah Rytter, Farkas, Dóra Körmendiné, Lohse, Nicolai, Skouby, Sven Olaf, Nielsen, Finn Erland, Lash, Timothy, Ehrenstein, Vera, Lohse, Sarah Rytter, Farkas, Dóra Körmendiné, Lohse, Nicolai, Skouby, Sven Olaf, Nielsen, Finn Erland, Lash, Timothy, and Ehrenstein, Vera
- Abstract
The purpose of this study is to validate the diagnosis of spontaneous abortion (SA) recorded in the Danish National Registry of Patients (DNRP).
- Published
- 2010
31. Polycystisk ovariesyndrom og komorbiditet
- Author
-
Haugaard, Line Klingen, Vestergaard, Henrik, Skouby, Sven Olaf, Haugaard, Line Klingen, Vestergaard, Henrik, and Skouby, Sven Olaf
- Abstract
Polycystic ovary syndrome (PCOS) is the most frequent endocrinological disorder among women in the reproductive age. It is by its very nature a heterogeneous juxtaposition of clinical and biochemical features. In women with PCOS, the most common clinical manifestations - obesity, hirsutism and oligomenorrhoea - are associated with insulin resistance, dyslipidaemia, hypertension, vascular dysfunction involving chronic inflammation and also reduced cardiopulmonary function. The focus of this overview is therefore on PCOS comorbidity with the metabolic syndrome, type 2 diabetes and cardiovascular diseases.
- Published
- 2010
32. Aortic dimensions in girls and young women with turner syndrome: a magnetic resonance imaging study
- Author
-
Cleemann, Line, Mortensen, Kristian H, Holm, Kirsten, Smedegaard, Heidi, Skouby, Sven O, Wieslander, Steen B, Leffers, Anne-Mette, Leth-Espensen, Per, Pedersen, Erik Morre, Gravholt, Claus H, Mortensen, Kristian Havmand, Skouby, Sven Olaf, Leffers, Anne Mette, Cleemann, Line, Mortensen, Kristian H, Holm, Kirsten, Smedegaard, Heidi, Skouby, Sven O, Wieslander, Steen B, Leffers, Anne-Mette, Leth-Espensen, Per, Pedersen, Erik Morre, Gravholt, Claus H, Mortensen, Kristian Havmand, Skouby, Sven Olaf, and Leffers, Anne Mette
- Abstract
Udgivelsesdato: 2010-May, This study aimed to determine the dimensions of the thoracic aorta and the predictors of aortic dimensions in girls and young women with Turner syndrome (TS). A cross-sectional study was performed at a secondary care center. The study compared 41 TS patients with 50 healthy age-matched control subjects. The mean age of the patients was 17 +/- 3.3 years. Magnetic resonance imaging was performed for all the patients. The thoracic aortic diameters of the patients were measured at nine positions. Adjustment for body surface area (BSA) was performed. The outcome for the patients was measured in terms of absolute and BSA-adjusted aortic dilation. In TS, both the absolute and the BSA-adjusted mean aortic diameters were smaller than or comparable with those of the control subjects. However, individual aortic dilation at one to four positions was found in four TS patients according to the uncorrected data and in five TS patients after BSA-adjustment. The aortic diameters correlated with height, weight, body mass index (BMI), and BSA at all positions (R = 0.34-0.60; all p < 0.04). The diameters of the aortic arch and the descending aorta correlated with a history of aortic coarctation (R = 0.35-0.52; p < 0.03). The presence of bicuspid aortic valves correlated at the descending part of the aorta (R = 0.38; p < 0.03). The mean thoracic aortic dimensions were not enlarged in girls or young TS patients. The BSA predicted aortic size at all positions. The prevalence of aortic dilation and aneurysm was lower in this population of girls and younger women with TS than in older TS populations.
- Published
- 2010
33. Skouby, Sven Olaf
- Author
-
Skouby, Sven Olaf and Skouby, Sven Olaf
- Published
- 2006
34. Assessment of endothelial function during oral contraception in women with insulin-dependent diabetes mellitus
- Author
-
Petersen, Kresten Rubeck, primary, Skouby, Sven Olaf, additional, Sidelmann, Johannes, additional, and Jespersen, Jørgen, additional
- Published
- 1994
- Full Text
- View/download PDF
35. CO2 Laser Vaporization in the Treatment of Cervical Human Papillomavirus Infection in Women with Abnormal Papanicolaou Smears
- Author
-
Ruge, Susanne, primary, Felding, Christine, additional, Skouby, Sven Olaf, additional, Lundvall, Finn, additional, Hørding, Ulla, additional, and Norrild, Bodil, additional
- Published
- 1992
- Full Text
- View/download PDF
36. Desogestrel and Gestodene in Oral Contraceptives: 12 Months’ Assessment of Carbohydrate and Lipoprotein Metabolism.
- Author
-
Petersen, Kresten Rubeck, Skouby, Sven Olaf, and Pedersen, Rikke GrØnholt
- Published
- 1991
37. Consequences of intrauterine contraception in diabetic women**The study of the corrosion investigations was supported by the Schering Company.
- Author
-
Skouby, Sven Olaf, Mølsted-Pedersen, Lars, and Kosonen, Ahti
- Abstract
A study has been performed covering the clinical consequences of copper intrauterine device insertion in 103 insulin-dependent women and in 119 nondiabetic control subjects. Furthermore, the progress of corrosion has been measured in 15 intrauterine devices removed from diabetic women, and the results were compared with data obtained from nondiabetic women. The clinical data did not reveal any differences in the total continuation rates or in the removal rates because of accidental pregnancy or pelvic inflammation between the diabetic and the nondiabetic women after 3 and 12months. Also, the maximal depth of corrosion as well as the distribution and the biochemical constitution of the corrosion products deposited on the copper wires were found identical in the two groups studied.
- Published
- 1984
- Full Text
- View/download PDF
38. Comparative Trial of the Effects on Glucose Tolerance and Lipoprotein Metabolism of two New Oral Contraceptives Containing Gestoden and Desogestrel
- Author
-
Petersen, Kresten Rubeck, Skouby, Sven Olaf, Dreisler, Anne, Kuhl, Claus, and Svenstrup, Birgit
- Abstract
The effects of two new low-dose oral contraceptives (triphasic ethinyl estradiollgestoden and monophasic ethinyl estradiolldesogestrel) on glucose tolerance, plasma insulin response to glucose, fasting plasma cortisol, triglycerides (TG), total cholesterol (C), HDL-C, LDL-C, VLDL-C and sex hormone binding globulin (SHBGI were investigated in two groups of healthy women (n = 10). Investigations were performed prior to hormone ingestion and after treatment for 2 and 6 months. In both groups, fasting plasma levels of glucose and insulin as well as the areas below the glucose concentration curves were unchanged during treatment, whereas the insulin response to oral glucose was equally increased (p >0.05). Intake of both compounds was followed by similar increases in the levels of HDL-C (p>0.05) and in the HDL-C/total-C (p > 0.05). A transient decrease in the levels of LDL-C was observed in both groups after two months. During intake of the gestoden-containing compound increases in VLDL-C and TG levels were registered after six months (p>0.05). Plasma levels of SHBG increased similarly in both groups (p>0.0l). The study indicates, that intake of both hormonal compounds is free from adverse effects on glucose tolerance and lipoprotein metabolism known to be of clinical significance. No differences in the metabolic effects were found between the two compounds.
- Published
- 1988
- Full Text
- View/download PDF
39. The influence on the pituitary-ovarian function, cervical mucus and vaginal cytology of a new progestational compound
- Author
-
Skouby, Sven Olaf, primary
- Published
- 1976
- Full Text
- View/download PDF
40. The short-term effects of a low-dose oral contraceptive on glucose metabolism, plasma lipids and blood clotting factors
- Author
-
Skouby, Sven Olaf, primary, Wagner, Hans Henrik, additional, and Andersen, Ole, additional
- Published
- 1983
- Full Text
- View/download PDF
41. Increased concentration of circulating atrial natriuretic peptide during normal pregnancy
- Author
-
Thomsen, Jørn Kvist, primary, Storm, Tommy Lyager, additional, Thamsborg, Gorm, additional, Nully, Michael de, additional, Bødker, Birgit, additional, and Skouby, Sven Olaf, additional
- Published
- 1988
- Full Text
- View/download PDF
42. Does adjuvant letrozole reduce uterine peristalsis prior to fresh embryo transfer?
- Author
-
Dreyer Holt M, Warzecha AK, Bülow NS, Skouby SO, Englund ALM, Birch Petersen K, and Macklon NS
- Abstract
Study Question: Does adjuvant letrozole in ovarian stimulation for IVF decrease the uterine peristalsis frequency (UPF) prior to fresh embryo transfer (ET)?, Summary Answer: Adjuvant letrozole in ovarian stimulation for IVF does not reduce the UPF significantly prior to fresh ET., What Is Known Already: Throughout the cycle, uterine peristalsis aids spermatozoa transport to the fallopian tube and may affect implantation. At fresh ET, UPF is negatively correlated with implantation and clinical pregnancy rates and is believed to be modulated by oestradiol and progesterone. High levels of oestradiol, from multiple follicular development, in ovarian stimulation have been reported to increase UPF, whereas progesterone is considered to be an utero-relaxant. The influence of androgens is unclear. Co-treatment with letrozole during gonadotropin ovarian stimulation limits the supra-physiological oestradiol rise and may therefore reduce UPF prior to fresh ET., Study Design Size Duration: This study was carried out on subjects participating in a single-centre double-blinded randomized controlled trial of the impact of letrozole on follicle development and endocrine profiles, and investigated the impact of adjuvant letrozole in ovarian stimulation for IVF on UPF prior to fresh ET and the correlations of UPF with endocrine markers. Between 2016 and 2017, 39 women expected to be normal responders were randomized to co-treatment with letrozole or placebo. Of these, 33 women completed this element of the study. The study was carried out according to the Helsinki Declaration and the ICH-Good-Clinical-Practice., Participants/materials Setting Methods: Eligible women were randomized 1:1 to adjuvant treatment with letrozole 5 mg/day or placebo in an antagonist protocol using a fixed dose of recombinant (r) FSH 150 IU/day. Final maturation was triggered with hCG 6500 IU and luteal support with vaginal progesterone was administered from the day following oocyte aspiration. Less than 1 h prior to fresh ET, 6-min duration transvaginal ultrasound recordings of the uterus in sagittal section were performed and blood samples were drawn., Main Results and the Role of Chance: A total of 33 women completed the study (letrozole n = 17; placebo n = 16). Age, BMI and ovarian reserve markers were similar between the groups. On the day of ET, serum oestradiol levels were significantly suppressed in the letrozole group to a mean of 867 ± 827 pmol/l compared to 3110 ± 1528 pmol/l in the placebo group ( P < 0.001). Mean UPF prior to fresh ET did not differ between the intervention and placebo group (3.3 ± 0.36 versus 3.5 ± 0.51 per minute respectively, P = 0.108). UPF was assessed and agreed by two observers who were blinded to adjuvant treatment. Two patients were excluded due to poor quality of the ultrasound recordings. Supra-physiological serum oestradiol in the placebo group were negatively correlated with UPF ( P = 0.014; R = -0.62), but the more physiological serum oestradiol levels in the letrozole group showed no correlation with UPF ( P = 0.567; R = 0.15). Serum progesterone levels were similar in both groups and did not show any significant correlation with UPF. Testosterone levels were significantly higher in the letrozole group ( P = 0.005) and showed a non-significant trend that negatively correlated with UPF in the placebo group ( P -value = 0.071, R = -0.48)., Limitations Reasons for Caution: Limitations of the study included the limited sample size and the lack of a power calculation specifically determined for this endpoint., Wider Implications of the Findings: The supra-physiological levels of oestradiol generated during ovarian stimulation were significantly suppressed in the intervention group. However, UPF prior to fresh ET was similar in both groups. Modulating the luteal phase sex steroids with adjuvant letrozole had little measured impact on UPF. Any beneficial effect of adjuvant letrozole during ovarian stimulation is unlikely to be due to significant modulation of UPF., Study Funding/competing Interests: M.D.H.'s salary was funded by an unrestricted research grant from Gedeon Richter. The expenses of the study were funded by a scientific collaboration: ReproUnion, co-financed by the European Union, Interreg Öresund-Kattegat-Skagerrak and Ferring Pharmaceuticals. The assays for the analyses were funded by Roche Diagnostics and an unrestricted research grant from Merck Life Science AS, Denmark. The authors have no competing interests to declare regarding this study., Trial Registration Number: Clinicaltrials.gov: NCT02939898, EudraCT no.: 2015-005683-41., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)
- Published
- 2022
- Full Text
- View/download PDF
43. [Increased morbidity risk in female athletes].
- Author
-
Olesen AG, Clausen HV, Skouby SO, Ottsen A, and Peen A
- Subjects
- Age Factors, Bone Density, Early Diagnosis, Energy Intake, Estrogen Replacement Therapy, Female, Female Athlete Triad Syndrome diagnosis, Female Athlete Triad Syndrome drug therapy, Female Athlete Triad Syndrome economics, Humans, Risk Factors, Female Athlete Triad Syndrome etiology
- Abstract
The female athlete triad refers to the interrelationships among energy availability, menstrual function and bone mineral density which may have clinical manifestations including eating disorders, functional hypothalamic amenorrhea and osteoporosis. The potentially irreversible consequences of these clinical conditions emphasize the critical need for prevention, early diagnosis and treatment. Nutritionally correct food ensuring optimal energy balance is a premise to improve these conditions. Alternative treatment is oestrogen replacement therapy which can prevent progressive bone loss.
- Published
- 2010
44. Validation of spontaneous abortion diagnoses in the Danish National Registry of Patients.
- Author
-
Lohse SR, Farkas DK, Lohse N, Skouby SO, Nielsen FE, Lash TL, and Ehrenstein V
- Abstract
Purpose: The purpose of this study is to validate the diagnosis of spontaneous abortion (SA) recorded in the Danish National Registry of Patients (DNRP)., Methods: We randomly selected patients registered in the DNRP with a diagnosis of SA between 1980 and 2008 from hospitals in the county of North Jutland and searched for their discharge records in hospital files. We estimated positive predictive value (PPV) of the DNRP diagnosis and stratified the analysis by period (1980-1994 versus 1995-2008), hospital type (regional versus local), and International Classification of Diseases revisions (ICD-8 versus ICD-10)., Results: We could identify hospital files of 117/174 (67%) sampled registration records. Of those, the diagnosis was confirmed in 114 patients, yielding a PPV of 97.4% (95% confidence interval = 92.7%-99.5%). The PPV did not markedly vary by period, hospital type, or ICD revision. Among the three patients with available data who did not fulfill the criteria for SA, one had an induced abortion and two had threatened abortion but did not miscarry., Conclusion: Registration of SA in the DNRP accurately reflects the diagnoses recorded in medical charts. The DNRP is a suitable source of data on SAs for epidemiologic research.
- Published
- 2010
- Full Text
- View/download PDF
45. [Polycystic ovary syndrome and comorbidity].
- Author
-
Haugaard LK, Vestergaard H, and Skouby SO
- Subjects
- Cardiovascular Diseases etiology, Diabetes Mellitus, Type 2 etiology, Female, Humans, Life Style, Metabolic Syndrome etiology, Polycystic Ovary Syndrome diagnosis, Polycystic Ovary Syndrome therapy, Risk Factors, Polycystic Ovary Syndrome complications
- Abstract
Polycystic ovary syndrome (PCOS) is the most frequent endocrinological disorder among women in the reproductive age. It is by its very nature a heterogeneous juxtaposition of clinical and biochemical features. In women with PCOS, the most common clinical manifestations - obesity, hirsutism and oligomenorrhoea - are associated with insulin resistance, dyslipidaemia, hypertension, vascular dysfunction involving chronic inflammation and also reduced cardiopulmonary function. The focus of this overview is therefore on PCOS comorbidity with the metabolic syndrome, type 2 diabetes and cardiovascular diseases.
- Published
- 2010
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.