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3. Prevention of multiple pregnancies in couples with unexplained or mild male subfertility : randomised controlled trial of in vitro fertilisation with single embryo transfer or in vitro fertilisation in modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation

Author

Bensdorp, A J, Tjon-Kon-Fat, R I, Bossuyt, P M M, Koks, C A M, Oosterhuis, G J E, Hoek, A, Hompes, P G A, Broekmans, F J M, Verhoeve, H R, de Bruin, J P, van Golde, R, Repping, S, Cohlen, B J, Lambers, M D A, van Bommel, P F, Slappendel, E, Perquin, D, Smeenk, J M, Pelinck, M J, Gianotten, J, Hoozemans, D A, Maas, J W M, Eijkemans, M J C, van der Veen, F, Mol, B W J, and van Wely, M

Published
2015

9. Are we overusing IVF?

Author

Evidence Based IVF Group, Kamphuis, Esme I, Bhattacharya, S, van der Veen, F, Mol, B W J, and Templeton, A

Published
2014

11. The randomised uterine septum transsection trial (TRUST): design and protocol

Author

Rikken, J. F. W., Kowalik, C. R., Emanuel, M. H., Bongers, M. Y., Spinder, T., de Kruif, J. H., Bloemenkamp, K. W. M., Jansen, F. W., Veersema, S., Mulders, A. G. M. G. J., Thurkow, A. L., Hald, K., Mohazzab, A., Khalaf, Y., Clark, T. J., Farrugia, M., van Vliet, H. A., Stephenson, M. S., van der Veen, F., van Wely, M., Mol, B. W. J., and Goddijn, M.

Published
2018
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21. Intracervical insemination versus intrauterine insemination with cryopreserved donor sperm in the natural cycle: a randomized controlled trial

Author

Kop, P A L, primary, van Wely, M, additional, Nap, A, additional, Soufan, A T, additional, de Melker, A A, additional, Mol, B W J, additional, Bernardus, R E, additional, De Brucker, M, additional, Janssens, P M W, additional, Pieters, J J P M, additional, Repping, S, additional, van der Veen, F, additional, and Mochtar, M H, additional

Published
2022
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29. CADANS: the nervous system for cardiology

Author

Meester, G. T., Sartorius, O. E. H., Fanggidaej, D., Gerritsen, M. G. J. M., Van Kester, J. A. T. G., Van Rappard-Van Der Veen, F. M., Meester, Geert T., editor, and Pinciroli, Francesco, editor

Published
1991
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31. Determinants of successful lifestyle change during a 6-month preconception lifestyle intervention in women with obesity and infertility

Author

Karsten, Matty D. A., van Oers, Anne M., Groen, Henk, Mutsaerts, Meike A. Q., van Poppel, Mireille N. M., Geelen, Anouk, van de Beek, Cornelieke, Painter, Rebecca C., Mol, Ben W. J., Roseboom, Tessa J., Hoek, Annemieke, Burggraaff, J. M., Kuchenbecker, W. K. H., Perquin, D. A. M., Koks, C. A. M., van Golde, R., Kaaijk, E. M., Schierbeek, J. M., Oosterhuis, G. J. E., Broekmans, F. J., Vogel, N. E. A., Lambalk, C. B., van der Veen, F., Klijn, N. F., Mercelina, P. E. A. M., van Kasteren, Y. M., Nap, A. W., Mulder, R. J. A. B., Gondrie, E. T. C. M., de Bruin, J. P., Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, Reproductive Origins of Adult Health and Disease (ROAHD), Value, Affordability and Sustainability (VALUE), Public and occupational health, Pediatric surgery, Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), ACS - Atherosclerosis & ischemic syndromes, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Plastic, Reconstructive and Hand Surgery, APH - Aging & Later Life, APH - Health Behaviors & Chronic Diseases, Graduate School, Obstetrics and Gynaecology, and Epidemiology and Data Science

Subjects
Counseling, Male, 0301 basic medicine, Gerontology, Lifestyle intervention, DIABETES PREVENTION PROGRAM, TERM WEIGHT-LOSS, Nutrition and Disease, Psychological intervention, Medicine (miscellaneous), Overweight, 0302 clinical medicine, Weight loss, Voeding en Ziekte, SOCIOECONOMIC-STATUS, PREDICTORS, Determinants, Nutrition and Dietetics, Preconception, Original Contribution, 3. Good health, Weight Reduction Programs, PREGNANCY, Female, medicine.symptom, Adult, Infertility, Adolescent, 030209 endocrinology & metabolism, HEALTH BEHAVIOR, Health Promotion, CLASSIFICATION, Young Adult, 03 medical and health sciences, Intervention (counseling), Weight Loss, CORONARY RISK-FACTORS, medicine, Humans, Obesity, Exercise, Life Style, Socioeconomic status, VLAG, Pregnancy, 030109 nutrition & dietetics, OVERWEIGHT, business.industry, Feeding Behavior, ADULTS, medicine.disease, business, Program Evaluation
Abstract

Purpose To identify demographic, (bio)physical, behavioral, and psychological determinants of successful lifestyle change and program completion by performing a secondary analysis of the intervention arm of a randomized-controlled trial, investigating a preconception lifestyle intervention. Methods The 6-month lifestyle intervention consisted of dietary counseling, physical activity, and behavioral modification, and was aimed at 5–10% weight loss. We operationalized successful lifestyle change as successful weight loss (≥ 5% weight/BMI ≤ 29 kg/m2), weight loss in kilograms, a reduction in energy intake, and an increase in physical activity during the intervention program. We performed logistic and mixed-effect regression analyses to identify baseline factors that were associated with successful change or program completion. Results Women with higher external eating behavior scores had higher odds of successful weight loss (OR 1.10, 95% CI 1.05–1.16). Women with the previous dietetic support lost 0.94 kg less during the intervention period (95% CI 0.01–1.87 kg). Women with higher self-efficacy reduced energy intake more than women with lower self-efficacy (p

Published
2019

32. Gonadotrophins versus clomiphene citrate with or without IUI in women with normogonadotropic anovulation and clomiphene failure: a cost-effectiveness analysis

Author

Bordewijk, E. M., Weiss, N. S., Nahuis, M. J., Bayram, N., van Hooff, M. H. A., Boks, D. E. S., Perquin, D. A. M., Janssen, C. A. H., van Golde, R. J. T., Lambalk, C. B., Goddijn, M., Hompes, P. G., van der Veen, F., Mol, B. W. J., van Wely, M., Smeenk, J. M. J., Hoek, A., Broekmans, F. J. M., Fleischer, K., de Bruin, J. P., Kaaijk, E. M., Laven, J. S. E., Hendriks, D. J., Gerards, M. H., Bourdrez, P., Gianotten, J., Koks, C., van Hooff, M., Kwee, J., Lambeek, A. F., van Unnik, A. F., Vrouenraets, F. P. J., Cohlen, B. J., van de Laar-van Asseldonk, T. A. M., Nap, A. W., van Rijn-van Weert, J. M., Vollebergh, J. H. A., Klijn, N. F., Rijnsaardt-Lukassen, H. G. M., Sluijmer, A. V., Gastroenterology & Hepatology, Obstetrics & Gynecology, Emergency Medicine, Erasmus School of Economics, Orthopedics and Sports Medicine, Neurology, Erasmus MC other, Obstetrics and gynaecology, APH - Health Behaviors & Chronic Diseases, Amsterdam Reproduction & Development (AR&D), VU University medical center, ACS - Atherosclerosis & ischemic syndromes, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Graduate School, APH - Methodology, APH - Personalized Medicine, ARD - Amsterdam Reproduction and Development, Center for Reproductive Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), and RS: GROW - R4 - Reproductive and Perinatal Medicine

Subjects
Male, Pregnancy Rate, Cost effectiveness, Cost-Benefit Analysis, medicine.medical_treatment, M-OVIN, law.invention, IUI, Indirect costs, 0302 clinical medicine, Randomized controlled trial, Pregnancy, law, FSH, Treatment Failure, 030212 general & internal medicine, Birth Rate, Insemination, Artificial, CLOMIFENE CITRATE, Netherlands, 030219 obstetrics & reproductive medicine, Obstetrics, Rehabilitation, CYCLES, Obstetrics and Gynecology, Health Care Costs, Cost-effectiveness analysis, POLYCYSTIC-OVARY-SYNDROME, Female, Live birth, Infertility, Female, Live Birth, Anovulation, Adult, medicine.medical_specialty, Clomiphene, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18], 03 medical and health sciences, clomiphene citrate, medicine, Humans, cost-effectiveness, gonadotrophins, business.industry, INFERTILE WOMEN, Fertility Agents, Female, medicine.disease, Pregnancy rate, OVULATION INDUCTION, Reproductive Medicine, polycystic ovary syndrome, SINGLETON, Ovulation induction, business, Gonadotropins
Abstract

STUDY QUESTION: Are six cycles of ovulation induction with gonadotrophins more cost-effective than six cycles of ovulation induction with clomiphene citrate (CC) with or without IUI in normogonadotropic anovulatory women not pregnant after six ovulatory cycles with CC?SUMMARY ANSWER: Both gonadotrophins and IUI are more expensive when compared with CC and intercourse, and gonadotrophins are more effective than CC.WHAT IS KNOWN ALREADY: In women with normogonadotropic anovulation who ovulate but do not conceive after six cycles with CC, medication is usually switched to gonadotrophins, with or without IUI. The cost-effectiveness of these changes in policy is unknown.STUDY DESIGN, SIZE, DURATION: We performed an economic evaluation of ovulation induction with gonadotrophins compared with CC with or without IUI in a two-by-two factorial multicentre randomized controlled trial in normogonadotropic anovulatory women not pregnant after six ovulatory cycles with CC. Between December 2008 and December 2015 women were allocated to six cycles with gonadotrophins plus IUI, six cycles with gonadotrophins plus intercourse, six cycles with CC plus IUI or six cycles with CC plus intercourse. The primary outcome was conception leading to a live birth achieved within 8 months of randomization.PARTICIPANTS/MATERIALS, SETTING, METHODS: We performed a cost-effectiveness analysis on direct medical costs. We calculated the direct medical costs of ovulation induction with gonadotrophins versus CC and of IUI versus intercourse in six subsequent cycles. We included costs of medication, cycle monitoring, interventions, and pregnancy leading to live birth. Resource use was collected from the case report forms and unit costs were derived from various sources. We calculated incremental cost-effectiveness ratios (ICER) for gonadotrophins compared to CC and for IUI compared to intercourse. We used non-parametric bootstrap resampling to investigate the effect of uncertainty in our estimates. The analysis was performed according to the intention-to-treat principle.MAIN RESULTS AND THE ROLE OF CHANCE: We allocated 666 women in total to gonadotrophins and IUI (n = 166), gonadotrophins and intercourse (n = 165), CC and IUI (n = 163), or CC and intercourse (n = 172). Mean direct medical costs per woman receiving gonadotrophins or CC were (sic)4495 versus (sic)3006 (cost difference of (sic)1475 (95% CI: (sic)1457-(sic)1493)). Live birth rates were 52% in women allocated to gonadotrophins and 41% in those allocated to CC (relative risk (RR) 1.24: 95% CI: 1.05-1.46). The ICER was (sic)15 258 (95% CI: (sic)8721 to (sic)63 654) per additional live birth with gonadotrophins. Mean direct medical costs per woman allocated to IUI or intercourse were (sic)4497 versus (sic)3005 (cost difference of (sic)1510 (95% CI: (sic)1492-(sic)1529)). Live birth rates were 49% in women allocated to IUI and 43% in those allocated to intercourse (RR = 1.14: 95% CI: 0.97-1.35). The ICER was (sic)24 361 (95% CI: (sic)-11 290 to (sic)85 172) per additional live birth with IUI.LIMITATIONS, REASONS FOR CAUTION: We allowed participating hospitals to use their local protocols for ovulation induction and IUI, which may have led to variation in costs, but which increases generalizability. Indirect costs generated by transportation or productivity loss were not included. We did not evaluate letrozole, which is potentially more effective than CC.WIDER IMPLICATIONS OF THE FINDINGS: Gonadotrophins are more effective, but more expensive than CC, therefore, the use of gonadotrophins in women with normogonadotropic anovulation who have not conceived after six ovulatory CC cycles depends on society's willingness to pay for an additional child. In view of the uncertainty around the cost-effectiveness estimate of IUI, these data are not sufficient to make recommendations on the use of IUI in these women. In countries where ovulation induction regimens are reimbursed, policy makers and health care professionals may use our results in their guidelines.STUDY FUNDING/COMPETING INTEREST(S): This trial was funded by the Netherlands Organization for Health Research and Development (ZonMw number: 80-82310-97-12067). The Eudract number for this trial is 2008-006171-73. The Sponsor's Protocol Code Number is P08-40. CBLA reports unrestricted grant support from Merck and Ferring. BWM is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for Merck, ObsEva and Guerbet.TRIAL REGISTRATION NUMBER: NTR1449.

Published
2019

33. Is IVF—served two different ways—more cost-effective than IUI with controlled ovarian hyperstimulation?

Author

Tjon-Kon-Fat, R.I., Bensdorp, A.J., Bossuyt, P.M.M., Koks, C., Oosterhuis, G.J.E., Hoek, A., Hompes, P., Broekmans, F.J., Verhoeve, H.R., de Bruin, J.P., van Golde, R., Repping, S., Cohlen, B.J., Lambers, M.D.A., van Bommel, P.F., Slappendel, E., Perquin, D., Smeenk, J., Pelinck, M.J., Gianotten, J., Hoozemans, D.A., Maas, J.W.M., Groen, H., Eijkemans, M.J.C., van der Veen, F., Mol, B.W.J., and van Wely, M.

Published
2015
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35. Cost-effectiveness of salpingotomy and salpingectomy in women with tubal pregnancy (a randomized controlled trial)

Author

Mol, F., van Mello, N.M., Strandell, A., Jurkovic, D., Ross, J.A., Yalcinkaya, T.M., Barnhart, K.T., Verhoeve, H.R., Graziosi, G.C., Koks, C.A., Mol, B.W., Ankum, W.M., van der Veen, F., Hajenius, P.J., van Wely, M., Janssen, Ineke C. A. H., Kragt, Harry, Hoek, Annemieke, Trimbos-Kemper, Trudy C. M., Broekmans, Frank J. M., Willemsen, Wim N. P., Dijkman, A. B., Thurkow, A. L., van Dessel, H. J. H. M., van der Linden, P. J. Q., Bouwmeester, F. W., Oosterhuis, G. J. E., van Beek, J. J., Emanuel, M. H., Visser, H., Doornbos, J. P. R., Pernet, P. J. M., Friederich, J., Strandell, Karin, Hogström, Lars, Klinte, Ingmar, Pettersson, F., Sabetirad, Z., Nilsson, K., Tegerstedt, G., and Platz-Christensen, J. J.

Published
2015
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37. Melanoma risk after ovarian stimulation for in vitro fertilization

Author

Spaan, M., van den Belt-Dusebout, A.W., Schaapveld, M., Mooij, T.M., Burger, C.W., van Leeuwen, F.E., Schats, R., Lambalk, C.B., Kortman, M., Laven, J.S.E., Jansen, C.A.M., Helmerhorst, F.M., Cohlen, B.J., Braat, D.D.M., Smeenk, J.M.J., Simons, A.H.M., van der Veen, F., Evers, J.L.H., and van Dop, P.A.

Published
2015
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40. Septum Resection Versus Expectant Management in Women With a Septate Uterus: An International Multicentre Open-Label Randomized Controlled Trial

Author

Rikken, J. F. W., primary, Kowalik, C. R., additional, Emanuel, M. H., additional, Bongers, M. Y., additional, Spinder, T., additional, Jansen, F. W., additional, Mulders, A. G. M. G. J., additional, Padmehr, R., additional, Clark, T. J., additional, van Vliet, H. A., additional, Stephenson, M. D., additional, van der Veen, F., additional, Mol, B. W. J., additional, van Wely, M., additional, and Goddijn, M., additional

Published
2021
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41. Septum resection versus expectant management in women with a septate uterus: an international multicentre open-label randomized controlled trial.

Author

Mol B.W.J., van der Veen F., van Wely M., Goddijn M., Rikken J.F.W., Kowalik C.R., Emanuel M.H., Bongers M.Y., Spinder T., Jansen F.W., Mulders A.G.M.G.J., Padmehr R., Clark T.J., van Vliet H.A., Stephenson M.D., Mol B.W.J., van der Veen F., van Wely M., Goddijn M., Rikken J.F.W., Kowalik C.R., Emanuel M.H., Bongers M.Y., Spinder T., Jansen F.W., Mulders A.G.M.G.J., Padmehr R., Clark T.J., van Vliet H.A., and Stephenson M.D.

Abstract

STUDY QUESTION: Does septum resection improve reproductive outcomes in women with a septate uterus? SUMMARY ANSWER: Hysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus. WHAT IS KNOWN ALREADY: A septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant. STUDY DESIGN, SIZE, DURATION: We performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12months after randomization, defined as the birth of a living foetus beyond 24weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI. MAIN RESULTS AND THE ROLE OF CHANCE: We randomly assigned 80 women with a septate uterus to septum resection (n=40) or expectant management (n=40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39=2.6%). LIMITATIONS, REASONS FOR CAUTION: Although this was a major interna

Published
2021

42. Septum Resection Versus Expectant Management in Women with a Septate Uterus: An International Multicentre Open-Label Randomized Controlled Trial.

Author

Rikken J.F.W., Kowalik C.R., Emanuel M.H., Bongers M.Y., Spinder T., Jansen F.W., Mulders A.G.M.G.J., Padmehr R., Clark T.J., Van Vliet H.A., Stephenson M.D., Van Der Veen F., Mol B.W.J., Van Wely M., Goddijn M., Rikken J.F.W., Kowalik C.R., Emanuel M.H., Bongers M.Y., Spinder T., Jansen F.W., Mulders A.G.M.G.J., Padmehr R., Clark T.J., Van Vliet H.A., Stephenson M.D., Van Der Veen F., Mol B.W.J., Van Wely M., and Goddijn M.

Published
2021

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