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Objective: The Natural Cycles app employs daily basal body temperature to define the fertile window via a proprietary algorithm and is clinically established effective in preventing pregnancy. We sought to (1) compare the app-defined fertile window of Natural Cycles to that of CycleProGo, an app that uses BBT and cervical mucus to define the fertile window and (2) compare the app-defined fertile windows to the estimated physiologic fertile window., Study Design: Daily BBT were entered into Natural Cycles from 20 randomly selected regularly cycling women with at least 12 complete cycles from the CycleProGo database. The proportion of cycles with equivalent (±1 cycle day) fertile-window starts and fertile-window ends was determined. The app-defined fertile windows were then compared to the estimated physiologic fertile window using Peak mucus to estimate ovulation., Results: Fifty seven percent of cycles (136/238) had equivalent fertile-window starts and 36% (72/181) had equivalent fertile-window end days. The mean overall fertile-window length from Natural Cycles was 12.8 days compared to 15.1 days for CycleProGo (p < 0.001). The Natural Cycles algorithm declared 12% to 30% of cycles with a fertile-window start and 13% to 38% of cycles with a fertile-window end within the estimated physiologic fertile window. The CycleProGo algorithm declared 4% to 14% of cycles with a fertile-window start and no cycles with a fertile-window end within the estimated physiologic fertile window., Conclusions: Natural Cycles designated a higher proportion of cycles days as infertile within the estimated physiologic fertile window than CycleProGo., Implications: Use of cervical mucus in addition to BBT may improve the accuracy of identifying the fertile window. Additional studies with other markers of ovulation and the fertile window would give additional insight into the clinical implications of app-defined fertile window differences., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To evaluate the cervical mucus effects of a norgestrel 0.075 mg progestin-only contraceptive pill over a 28-day cycle., Study Design: We recruited persons ages 18 to 35 with normal cycles at 2 US academic medical centers. Participants took norgestrel 0.075 mg daily for 28 days at the same time (within a 3 hour window) daily, recorded through a text-message based e-diary. We extracted cervical mucus using a standardized aspiration technique on the day of pill initiation and then at least every 3 to 4 days over the cycle. We monitored subjects for follicular activity with transvaginal ultrasound examination and blood sampling for ovarian hormones and gonadotropins at each visit. We assessed cervical mucus scoring using a 4-category/12-point modified Insler scale (score ≥9 [favoring fertility], 5-8 [intermediate], and ≤4 [unfavorable to fertility]). We stratified cervical mucus scores by serum estradiol levels and ovulatory status based on a modified Hoogland score., Results: Excluding enrollment, we collected and evaluated 413 mucus samples from 51 participants. Participants had a median mucus score of 0 (Interquartile Range 0, 2); most had scores ≤4 (samples = 385, 93%) and none had a score ≥9 favoring fertility. Seventeen (33%) participants ovulated, of which 14 (82%) had unfavorable mucus scores (≤4) at the time of ovulation and 3 (18%) had intermediate scores (5-8)., Conclusions: Norgestrel 0.075 mg daily prevents mucus changes that favor fertility, even during ovulatory cycles., Implications: Daily administration of norgestrel 0.075 mg over an initial 28-day cycle did not result in fertile cervical mucus. Although approximately one-third of users ovulated in this first cycle of pill use, contraceptive efficacy may be maintained by mucus effects., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

DNA transfer is a well-recognised phenomenon impacting the probability of detecting the presence of a particular source of DNA and thus the likelihood of the evidence given considered events within forensic investigations. Comprehensive study is lacking on variables associated with indirect DNA transfer without physical contact. Additionally, the drying properties of forensically relevant biological materials are under researched despite the recognised potential for these properties to affect DNA transfer. This study investigated the drying properties and indirect DNA transfer of dried blood, saliva, semen, vaginal fluid and touch DNA without contact deposited on two different non-porous hard substrates (melamine and glass) and two different porous soft substrates (polyester and cotton) by tapping (all substrates) and stretching (only fabric substrates) agitations. Different apparent drying trends were observed between the volumes, substrates and biological materials tested with substrate type generally having a greater influence than biological material. The rate and percentage of indirect transfer appeared to be dependent on agitation, substrate type, biological material and its drying properties. The outcomes of this study may assist those evaluating the likelihood of the evidence given proposed events during activity level assessments., (Copyright © 2020 Elsevier B.V. All rights reserved.)

In a previous EUROFORGEN/EDNAP collaborative exercise, we tested two assays for targeted mRNA massively parallel sequencing for the identification of body fluids/tissues, optimized for the Illumina MiSeq/FGx and the Ion Torrent PGM/S5 platforms, respectively. The task of the second EUROFORGEN/EDNAP collaborative exercise was to analyze dried body fluid stains with two different multiplexes, the former Illumina 33plex mRNA panel for body fluid/tissue identification and a 35plex cSNP panel for assignment of body fluids/tissues to donors that was introduced in a proof-of-concept study recently. The coding region SNPs (cSNPs) are located within the body fluid specific mRNA transcripts and represent a direct link between the body fluid and the donor. We predicted the origin of the stains using a partial least squares discriminant analysis (PLS-DA) model, where most of the single source samples were correctly predicted. The mixed body fluid stains showed poorer results, however, at least one component was predicted correctly in most stains. The cSNP data demonstrated that coding region SNPs can give valuable information on linking body fluids/tissues with donors in mixed body fluid stains. However, due to the unfavorable performance of some cSNPs, the interpretation remains challenging. As a consequence, additional markers are needed to increase the discrimination power in each body fluid/tissue category., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Combined hormonal contraceptives (CHCs) are popular methods of reversible contraception in the United States, but adherence remains an issue as reflected in their lower rates of typical use effectiveness. The objective of this systematic review was to evaluate evidence on the effect of missed CHCs on pregnancy rates as well as surrogate measures of contraceptive effectiveness (e.g., ovulation, follicular development, changes in hormone levels, cervical mucus quality)., Study Design: We searched the PubMed database for peer-reviewed articles published in any language from database inception through April 2012. We included studies that examined measures of contraceptive effectiveness during cycles with extended hormone-free intervals or nonadherence (e.g., omission of pills, delayed patch replacement) on days not adjacent to the hormone-free interval. We used standard abstract forms and grading systems to summarize and assess the quality of the evidence., Results: The search strategy identified 1387 articles, of which 26 met our study selection criteria. There is wide variability in the amount of follicular development and risk of ovulation among women who extended the pill-free interval to 8-14 days; in general, the risk of ovulation was low, and among women who did ovulate, cycles were usually abnormal (i.e., low progesterone levels, small follicles and/or poor cervical mucus) (Level I, good, indirect to Level II-3, fair, indirect). Studies of women who missed one to four consecutive pills or 1-3 consecutive days of delay before patch replacement at times other than adjacent to the hormone-free interval reported little follicular activity and low risk of ovulation (Level I, fair, indirect to Level II-3, poor, indirect). Studies comparing 30 mcg versus 20 mcg mc ethinyl estradiol pills showed more follicular activity when 20 mcg ethinyl estradiol pills were missed (Level I, good, indirect)., Conclusion: Most of the studies in this evidence base relied on surrogate measures of pregnancy risk and ranged in quality. For studies providing indirect evidence on the effects of missed CHCs, it is unclear how differences in surrogate measures correspond to pregnancy risk. Fewer studies examined the transdermal patch and vaginal ring than combined oral contraceptives., (Published by Elsevier Inc.)

Fertility is a very complex biological function that depends on several properties of the spermatozoa, including sperm motility. Two objectives are analyzed in this study: (1) Replace the cervical mucus by a synthetic medium in a sperm penetration test, and (2) evaluating the results of this test objectively analyzing the sperm number that migrates. In experiment 1, we have tested eight concentrations of acrylamide (1%-2%). Rheological properties of media were analyzed. The plastic straws, loaded with acrylamide, were placed vertically on the semen sample tube for 15 min at 39 °C. After, the acrylamides were placed, by segments of 5 mm, into wells of a 24-well plate, dyed with Hoechst 33342 and the number of spermatozoa were calculated by automated microscopy analysis. The 1.55% and 1.6% acrylamide gel showed a number of spermatozoa emigrating closer to that seen with natural mucus. In experiment 2, we applied the sperm penetration in acrylamide 1.6% and 1.55% using fresh semen and cooled semen at 15 °C and 5 °C. The spermatozoa counts were performed for each segment of 10 mm. Semen chilled at 15 °C presented intermediate values of sperm counts in comparison with fresh semen (higher) and 5 °C chilled semen. The sperm counts do not differ between acrylamides but the rheological properties of acrylamide 1.6% were more similar to those of the natural cervical mucus. In experiment 3, we have observed significant correlations between the number of spermatozoa and several sperm quality parameters (positive: progressive motility and velocity according to the straight path; negative: damaged acrosomes and apoptotic cells) in 1.6% acrylamide media. We conclude that the size of the cell subpopulation, objectively calculated, that migrate beyond 20 mm in 0.5-mL straws filled with acrylamide is a useful parameter in ram sperm quality assessment and further studies are needed to evaluate its relationship with field fertility., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Rupture of membranes (ROM) occurs frequently and requires specific management depending on gestational age in order to avoid maternal and fetal complications. In 80% of cases, ROM is associated with large amniotic fluid (AF) leakage making diagnosis easy. The aim of the current review is to precise which biological test is useful for the physician facing ambiguous clinical picture. Vaginal pH assessment demonstrates alkalinisation (6.5-7.5) when AF is present (sensitivity 73-91%, specificity 72-83%). Drying test, fern test or fetal cells staining have been supplanted by detection of AF proteins. Diamine oxidase activity required specific radioanalytical assay leading to restrictive use and progressive abandon. Immunoassay tests detecting Insulin-like Growth Factor-Binding Protein-1 (IGFBP-1) or Placental Alpha 1-Microglobulin (PAMG-1) are currently considered as the most useful tools for ROM diagnosis. Literature fails to provide sufficient evidence that one of these two approaches should be favoured. Distinction between IGFBP-1 and PAMG-1 remains controversial as they seem to correspond to the same molecule., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

The preservation of the genetic diversity of captive populations of rhesus monkeys is critical to the future of biomedical research. Cryopreservation of rhesus macaque sperm is relatively simple to perform, yields high post-thaw motility, and theoretically, provides via artificial insemination (AI) a way to easily transfer genetics among colonies of animals. In the interest of optimizing semen cryopreservation methods for use with vaginal AI, we evaluated the ability of frozen-thawed rhesus sperm to penetrate periovulatory cervical mucus (CM). Motile sperm concentration of pre-freeze ("fresh") and post-thawed ("thawed") samples from five different males were normalized for both computer assisted sperm motion analysis and CM penetration experiments. Sperm samples were deposited into slide chambers containing CM or gel composed of hyaluronic acid (HA) as a surrogate for CM and numbers of sperm were recorded as they entered a video field a preset distance from the sperm suspension-CM (or HA) interface. Fresh and thawed sperm were dried on glass slides, "Pap"-stained, and assessed for changes in head dimensions and head and flagellar shape. While retaining better than 80% of fresh sperm progressive motility, thawed sperm from the same ejaculate retained on average only 18.6% of the CM penetration ability. Experiments using HA gel yielded similar results only with reduced experimental error and thus improved detection of treatment differences. Neither the percentage of abnormal forms nor head dimensions differed between fresh and thawed sperm. While findings suggests that sperm-CM interaction is a prominent factor in previous failures of vaginal AI with cryopreserved macaque sperm, neither sperm motility nor morphology appears to account for changes in the ability of cryopreserved sperm to penetrate CM. Our data points to a previously unidentified manifestation of cryodamage which may have implications for assessment of sperm function beyond the cervix and across mammalian species., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Background: This study was conducted to compare the effectiveness of a new, single-size silicone contraceptive diaphragm used with either spermicide [2% nonoxynol-9 (N-9)] or lubricant in preventing sperm from penetrating midcycle cervical mucus., Study Design: A crossover postcoital test (PCT) in healthy, sexually active women not at risk for pregnancy due to tubal occlusion was conducted. Couples had a baseline PCT without a device to verify normal fertility parameters. Qualified couples underwent up to two test cycles using the SILCS diaphragm with a metal spring. A subgroup of couples underwent a third test cycle with the SILCS polymer spring diaphragm used with N-9 gel., Results: Fifteen couples completed a baseline cycle and were randomized to order of study gel. Of these, 14 couples completed a baseline cycle and at least one test cycle, 12 couples completed a baseline cycle and two test cycles and 8 couples completed a third test cycle with the polymer spring prototype. Sperm was detected in the vaginal pool in all completed test cycles. The SILCS metal spring diaphragms used with N-9 gel reduced the average number of progressively motile sperm per high power field in the cervical mucus from a baseline of 12.5 to 0, while use of this device with lubricant reduced the number to 0.5. The SILCS polymer spring diaphragm used with N-9 performed the same as the metal spring used with N-9., Conclusion: The SILCS diaphragm used with N-9 gel performed well. It is likely that the SILCS diaphragm will give acceptable results in a contraceptive effectiveness study but that adjunctive use of a chemical barrier such as N-9 gel will be necessary for it to be most effective.

Context: Fertility awareness-based (FAB) methods of family planning estimate the fertile days of the menstrual cycle whether by observing fertility signs such as cervical secretions and basal body temperature or by monitoring cycle days. The efficacy and acceptability of these methods are unclear., Methods: We retrieved and analyzed all randomized controlled trials that examined any FAB method used for contraception., Results: Because of poor methods and reporting, pregnancy rates could not be determined. A trial in Colombia found similar numbers of pregnancies among women randomized to the ovulation and symptothermal methods, but a trial in Los Angeles observed more pregnancies in the group assigned to the ovulation method. In the two American trials, recruitment of participants was unexpectedly difficult. Continuation rates were poor., Conclusion: Despite intensive training and ongoing support, most participants in these trials discontinued prematurely. The comparative efficacy of these methods remains unknown. However, with the ovulation and symptothermal methods, pregnancies appear to be common; method continuation rates are low.

The effect of processing prior to sex-sorting, re-freezing and thawing of frozen-thawed bull spermatozoa on in vitro sperm characteristics was investigated. Frozen-thawed bull spermatozoa (three bulls; three ejaculates per bull) were prepared for sorting by washing (FT-WASH) or gradient centrifugation (FT-GRADIENT) and evaluated for motility and forward progressive motility (FPM) after processing, staining, sorting and incubation (3 h; 37 degrees C). After frozen-thawed samples were processed and analyzed using a high-speed cell sorter, aliquots were removed and re-frozen and thawed (FTF-WASH; FTF-GRADIENT). Non-sorted frozen-thawed spermatozoa (FT-CONTROL) were also re-frozen and thawed (FTF-CONTROL). Spermatozoa from all treatments were assessed for penetration of an artificial cervical mucus at 0 h after sorting or thawing, and for motility, FPM and acrosomal status after 3-h incubation (37 degrees C). Frozen-thawed spermatozoa prepared by gradient centrifugation before sorting were sorted more efficiently than washed samples (P < 0.05). However, after sorting (FT) or thawing (FTF) and incubation, the percentage of motile spermatozoa and FPM rating was lower for GRADIENT than WASH (21.5 +/- 3.39%; 1.4 +/- 0.16 FPM versus 48.6 +/- 4.02%, 2.6 +/- 0.16 FPM; P < 0.01). Frozen-thawed sorted spermatozoa (FT) penetrated in greater numbers (151.0 +/- 19.50 spermatozoa) and distance (56.3 +/- 5.11 mm) in the artificial cervical mucus and had a higher proportion of motile spermatozoa (65.5 +/- 2.77%) and FPM rating (2.8 +/- 0.12) after incubation than spermatozoa that had been re-frozen and thawed after sorting (FTF: 14.0 +/- 3.67 spermatozoa, 21.6 +/- 3.05 mm, 12.2 +/- 1.31% and 1.2 +/- 0.10 FPM, respectively; P < 0.001). Regardless of processing prior to sorting, frozen-thawed sorted and non-sorted spermatozoa migrated similar distances in the artificial cervical mucus (FT-WASH: 60.0 +/- 1.2 mm; FT-GRADIENT: 57.2 +/- 0.76 mm; FT-CONTROL: 51.7 +/- 0.69 mm). The results of this preliminary study suggested that frozen-thawed bull spermatozoa can be efficiently sorted into high purity X- and Y-chromosome enriched samples with retained functional capacity.

Embryo transfer is an important step in the success of IVF treatment. All efforts should be made to avoid difficult embryo transfers provoking bleeding or uterine contractions. Evaluation before IVF treatment, including a trial transfer and a uterine ultrasonography, should allow one to evaluate the transfer step, anticipate problems, and thus improve treatment. An hysteroscopy can be useful for uterine cavity exploration. It is also important to remove cervical mucus before introduce the transfer catheter. It is essential to deposit embryos as gently as possible during IVF, avoiding manoeuvres that might trigger uterine contractions which could adversely affect the results of this treatment. Soft catheters perform better, and ultrasound-guidance facilitates embryo transfer. Progesterone administration starting on the day of oocyte retrieval induces a decrease in uterine contraction frequency on the day of ET (embryo transfer). Both Wallace and CDD catheters perform similarly. Trial catheterization on the day of ET could prevent most of the unanticipated procedural difficulties during the transfer.

There are many potential mechanisms of action for the intrauterine device (IUD), which vary by type of IUD (inert, copper, or hormonal). This paper reviews the evidence for each potential mechanism of action. On the basis of available data for fertilization rates and clinical pregnancy rates, the relative contribution of mechanisms acting before or after fertilization were quantitatively estimated. These estimates indicate that, although prefertilization effects are more prominent for the copper IUD, both prefertilization and postfertilization mechanisms of action contribute significantly to the effectiveness of all types of intrauterine devices.

Sperm migration in estrous cervical mucus can be used to measure the ability of spermatozoa to migrate through the genital tract. The relationship of this test with the sperm colonization of the isthmus, and its impact on fertility has not been evaluated in goats. Our objectives were to determine the differences among spermatozoa of different bucks in their ability to penetrate homologous cervical mucus in vitro and to determine the relationship between sperm displacement through cervical mucus and the ability of spermatozoa to colonize the oviduct and penetrate IVM oocytes, in vivo. Sperm migration in cervical mucus was assessed in flat capillary tubes with a phase contrast microscope. In the first experiment, fresh semen was used to establish differences between males in the ability of their spermatozoa to migrate in cervical mucus. In the second experiment, goats in estrus were inseminated with fresh spermatozoa from males with significant differences in mucus migration ability, and sperm numbers were evaluated at the UTJ. In the third experiment, the fertilization efficiency of IVM oocytes transferred to the oviduct of estrous females inseminated with semen from the same males as earlier, was used to assess the relationship between the mucus migration test and the in vivo fertilization performance of their spermatozoa. Spermatozoa from different males varies significantly in sperm migration efficiency in cervical mucus (15.5a +/- 1.2; 14.9a +/- 1.4; 17.5ab +/- 1.2; 17.0ab +/- 1.5; 19.7b +/- 1.2; 20.1b +/- 1.4 mm; media +/- S.E.M. for males A-F, respectively, P < 0.05). Spermatozoa from males with different mucus migration efficiency values produced different sperm populations at the oviduct reservoir of inseminated females (1,233 +/- 92.3 versus 28.8 +/- 17.0 spermatozoa of males with high and low relative migration efficiency, respectively, P < 0.02). Spermatozoa from males with different mucus migration efficiency values have different fertilization rates of IVM oocytes transferred to oviduct (47/96 (49.0%) versus 25/91 (27.5%) for males with high and low relative migration efficiency, respectively, P < 0.05). Cumulative results suggest that sperm migration in cervical mucus is related to the ability of spermatozoa to colonize the oviduct and to fertilize matured oocytes in vivo.

This study was designed to describe an accurate and consistent microscopic technique for the assessment of sperm number and motility in sperm-cervical mucus samples, such as those of postcoital tests (PCTs), and to identify a suitable method to extract functional spermatozoa from cervical mucus (CM). Sperm-CM preparations containing various sperm concentrations were counted using three different microscopic illuminations. The dark field-Makler technique was compared with the more classical bright field-slide technique currently used by our clinicians. Several sperm extraction techniques were applied first to bovine (BCM) and then to human (HCM) cervical mucus. Dark field microscopic illumination provided accurate, fast, and easy sperm identification. Counting variability was significantly greater with bright field-slide than with dard field-Makler, while sperm motility was always higher with this latter methodology. A high degree of agreement (intraclass correlation coefficient = 0.965) among three raters, i.e., low interobserver variability, was obtained only with dark field-Makler. Extraction procedures based on "swim-out," Percoll, trypsin, an enzyme cocktail, and mercaptoethanol resulted in small sperm yields in BCM. Mercaptoethanol and trypsin also showed poor sperm recovery in HCM. Among the protocols with the largest yields, the mechanical technique had the largest amount of residual CM, and bromelain reduced sperm motility. The extraction with dithiothreitol (DTT) showed the best results with a mean sperm recovery of 76% and enhanced sperm motility. Sperm viability as well as spontaneous and induced acrosome reaction were conserved in all techniques. In conclusion, use of the dark field-Makler counting technique in combination with DTT extraction of spermatozoa from CM samples, such as those of PCTs, would allow accurate and functional assessment of spermatozoa for preliminary contraceptive efficacy or infertility evaluation.

The aim of this study was to evaluate the effectiveness of lactational amenorrhoea and to determine the relationship between extended breastfeeding and the return of fertility. Breastfeeding pattern, basal body temperature, cervical mucus, salivary ferning, vaginal blood discharge, frequency of sexual intercourse, and the presence of ovulation in the first cycle after the resumption of menses with ultrasonography were evaluated in 40 women. All subjects completed the study with only one case of incomplete breastfeeding. No pregnancies were observed. The mean number of feeding sessions and mean interval between sessions decreased significantly (p <0.01) during the first six months postpartum (7.5 +/- 1.3 after 60 days postpartum vs. 5.7 +/- 2.1 after 180 days, and 3.6 +/- 0.8 vs. 5.1 +/- 0.9, respectively). Eight women (20%) menstruated before weaning, but none had an adequate thermal shift, while 32 (80%) had their first vaginal bleeding after weaning with 12 (37.5%) registering an adequate thermal shift. Both basal body temperature and salivary ferning proved to be suggestive of ovarian activity, while mucus characteristics were not reliable in identifying fertile periods. Our study showed that breastfeeding associated with lactational amenorrhoea proved to be a good method of postpartum fertility control. Since the importance of supplementation is still debated, it is recommended that a "complete" breastfeeding program be used.

Unlabelled: A Belgian pilot-study conducted in the framework of the prospective European multi-center study (University of Düsseldorf) tried to establish the use-effectiveness (a sine qua non condition for its acceptance in Europe) of natural family planning., Material and Methods: 84 participants provided data (sympto-thermal chart and related information) on 1,750 cycles where family planning intention was to avoid a pregnancy. The average age of the women was 32 years. A contraceptive method (mainly oral contraceptives) was employed previously by 61% of them. The sympto-thermal method used by the test group highlights the beginning and the end of the menstrual cycle's fertile period by a double check. As to the start of the fertile period, the criteria are: a calculation on the length of the previous twelve cycles and the first sign of mucus at either the vulva or the cervix. Indicators of the end of this phase are: the third day of high temperature and the fourth evening after either the peak mucus day or the peak cervix day. 75% of the women involved generally use the cervical auto-palpation., Results: No method failure at all has been detected. Two unplanned pregnancies occurred due to user failure. The total Pearl index for the study was 1.4. When examining only those cycles (85% of the reported cycles) where no protected sexual intercourse occurred during the fertile phase, practical efficacy of the method analysed was 1.8 according to Pearl index. Furthermore, taking into account protected and unprotected sexual intercourse occurred during the fertile phase, we observed that sexual abstinence was practised during the "risk" period of 75% of the cycles., Conclusions: The results of this test study demonstrate the practical efficiency of a modern natural family planning method. The high level of cycles during which periodic abstinence was employed testify to the acceptability of the method used.

Gramicidin, a linear polypeptide with antiviral and antimicrobial properties, was compared in vitro with a commonly used spermicidal detergent-nonoxynol-9 (N9). The inhibition of sperm functions was evaluated by computer-assisted semen analysis (CASA) for sperm motility, in cervical mucus penetration assay, and by colorimetric tetrazolium salt and lactate dehydrogenase release assays routinely employed for testing the toxicity of drugs. The effective 100% inhibitory concentration (IC100) of gramicidin in a 2-min sperm immobilization assay by CASA was equal to 4 micrograms/ml, whereas IC100 of N9 was equal to 200 micrograms/ml. The presence of 0.1% of chelating agent, EDTA, reduced IC100 of gramicidin to 10 ng/ml, while less than a twofold enhancement in N9 activity was observed upon combination with EDTA. Likewise, the gramicidin/EDTA combination was 100,000 times more potent than N9/EDTA in the sperm penetration assay. Quantitative toxicity tests confirmed that gramicidin is a potent spermostatic rather than spermicidal agent. Further development of a gramicidin/EDTA formulation is warranted as a nontoxic topical contraceptive with activity against viral and microbial sexually transmitted diseases (STDs).

There are couples with unmet family planning needs and couples who do not use any modern method, yet they desire to space or avoid pregnancies. Many of them look for safe and effective options like the natural family planning methods. The Billings Ovulation Method based on single index cervical mucus parameter is one such option. The present multicentre trial conducted in India has shown an encouraging use-effectiveness of the method, indicating method failure as low as 1.5 +/- 0.3 and use-failure 15.9 +/- 0.8 per 100 users at 21 months. The method continuation rates have also been as high as 88.3/100 users at 6 months and 52.0/100 users at 21 months.

Primates (Erythrocebus patas) were implanted with intracervical devices which slowly released d-norgestrel at either of two rates: 38 +/- 12 microgram/day (high dose, 4 animals) or 14 +/- 10 microgram/day (low dose, 3 animals). An additional 8 animals received placebo devices or were untreated controls. All animals were studied for 3 months of exposure, at which time they were necropsied and evaluated. The uterus in all of the high dose primates had endometrial stromal and epithelial hyperplasia and, in two primates, suppurative endometritis. Similar, but less severe, uterine changes were present in animals of the low dose group. Systemic effects included evidence of diminished menstrual cycling and an absence of corpora lutea at both dose levels. Our results indicate that local application of these levels of d-norgestrel for contraception produces effects similar to those from systemically administered d-norgestrel.

The records of 159 women who underwent 561 cycles of donor insemination (AID) in the UCD artificial insemination program were analyzed in a study of the relationship of the numbers of motile sperm seen in the cervical mucus 48 hours after AID with subsequent fertility. The numbers of motile sperm were expressed on an integral rank scale (0 to 8). A relationship between the results and subsequent fertility was demonstrated. The distribution of the data on sperm numbers for fertile and infertile cycles were qualitatively and quantitatively different. The latter were consistently skewed toward low values, while the former were not. Overall, mean values were higher for conception cycles. Selective grouping of women to eliminate factors that could potentially have an adverse influence on fertility, such as pelvic abnormality, oligoovulation, or prior pelvic operation, increased the overall conception rate. However, they did not influence the relationship between low and high motile sperm numbers and subsequent conception.

To ascertain the effects of low-dosage cyproterone acetate (CPA) on the reproductive and endocrine functions of normal men, 25 volunteers were given CPA 0, 5 or 10 mg daily over 16 weeks, preceded by 12 weeks pretreatment observation and followed by 24 weeks posttreatment follow-up. CPA caused a decrease in sperm concentration, percentage motility, proportion of normal sperm and ability of the sperm to penetrate a column of cervical mucus in most patients. In addition, circulating testosterone, estradiol, LH and FSH levels were significantly reduced during treatment. All these changes reverted to the pretreatment level upon drug withdrawal. These findings suggest that firstly, although low dosage CPA was able to induce changes in seminal analyses, azoospermia was present in only one out of 15 subjects exposed to the drug. Secondly, the marked decrease in androgen levels associated with CPA treatment renders CPA unsuitable as a single entity agent for long-term male contraception.

Some biological and biochemical effects (i.e. KPI, cervical mucus, SHBG and ceruloplasmin) as well as serum ethynylestradiol and serum norgestrel, following the use of two oral contraceptives containing the same amount of norgestrel (dl-norgestrel 0.5 mg) and either 30 microgram or 50 microgram of ethynylestradiol were compared. There was no difference in the clinical features in either group of patients. There was a statistically significant difference in the levels of unconjugated ethynylestradiol but not in the other biochemical parameters studied. It is concluded that the absence of any such difference might be attributable to the strong antiestrogenic effects of dl-norgestrel.

Filtering sperm through glass fiber has been suggested as a method for improving its fecundity before homologous artificial insemination. Various technical modification of this procedure have enabled good results to be obtained on spermatozoid mobility but at the expense of a marked drop in numbers: sperm counts per ml are diminished by a half. A comparative in vitro study of the penetration of filtered and non-filtered sperm into the cervical mucus showed that glass fiber filtration produced generally no great improvement, and may indeed reduce penetration into the cervical mucus to a marked degree in some cases.

Predicting ovulation is the basis on which the fertile period is determined. When we carried out observations on 60 spontaneous cycles it was possible to detect with precision the discharge of LH which would produce ovulation by taking series of plasma levels of LH. The start is defined as the time when the level of LH becomes 180% greater than the mean level observed in the previous 24 hours. Ovulation occurs between 37 and 39 hours after this threshold has been crossed. The discharge of LH is the most constant criterion and the most precise one, and it does make it possible to work out the chronology of the events that precede ovulation. Ultrasound and estimation of levels of oestradiol in the plasma or in the urine do allow one to appreciate how the follicle is maturing.

A sulfonated polystyrene polymer, ORF 13904, was discovered in our laboratory to be a highly effective vaginal contraceptive in the rabbit model and to possess a unique mode of action. It was found to be non-spermicidal even at high concentrations, yet it greatly impeded sperm penetration of cervical mucus in vitro. When a gel formulation containing 5% ORF 13904 was administered to rabbits intravaginally, the mean number of fetal implants was reduced dramatically even when coitus was delayed for up to 8 hours or when multiple matings at different time intervals were permitted. The non-spermicidal qualities and extended duration of action of this compound represent major breakthroughs in the development of vaginal contraceptives.

The crystallization phenomenon of human midcycle cervical mucus was studied with purified mucin and sodium chloride. The drying of the purified mucin in saline was subjected to stress by the use of an air curtain, and crystallization (fern pattern) was found to follow the stress. Lithium chloride and calcium chloride were not compatible with the mucin for the formation of fernlike crystals. When a dilute solution of mucin dissolved in saline was dried, a radial crystallization pattern was observed to emanate from a single crystal in the center. Upon closer examination, the pattern was observed to emanate from the corners of the crystal.

Modern techniques of bioassay have permitted correlation of hormonal secretion with genital tissue changes during the normal menstrual cycle. During the follicular phase, estrogen secretion rises while other hormone levels are low. At ovulation luteinizing hormone and follicle-stimulating hormone surges are associated with falling estrogen levels. Secretions of progesterone and estrogen again are characteristic of the luteal phase ending with menstruation. Gonadotrophin-releasing hormones are detectable just before the luteinizing hormone and follicle-stimulating hormone surges. Basal body temperature rises with ovulation and is still the most reliable clinical indicator, although ferning and spinnbarkeit (when present) are also quite helpful. Vaginal smears are probably less useful except in the hands of experienced observers.