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PubMed1997

A phase I comparative study of contraceptive vaginal films containing benzalkonium chloride and nonoxynol-9. Postcoital testing and colposcopy.

Benzalkonium chloride (BZK) has been shown in in vitro and in vivo studies to immobilize sperm, to be active against STD-causing organisms, and to penetrate and thicken cervical mucus. A US clinical study of a sponge containing 60 mg BZK showed life table pregnancy rates at 6 and 12 months of 11.7 and 18.9 per 100 women, respectively. BZK is not currently marketed in the US as a contraceptive. The present study aimed to assess 1) the ability of a new contraceptive vaginal film containing either of two doses of BZK to prevent the penetration of sperm into midcycle cervical mucus; 2) the effect of the film on the vaginal epithelium; and 3) the acceptability of the film. All results were compared with VCF, a currently marketed film containing nonoxynol-9 (N-9). Ten women underwent two baseline cycles of postcoital testing in which no film was used, followed by three test cycles in which Allendale-BZK film, a new film containing either 19 or 25 mg BZK, or VCF, containing 70 mg N-9, was used. The sequence of testing cycles was randomized. In each cycle, condoms were used prior to midcycle, then a midcycle cervical mucus specimen was examined to ensure midcycle characteristics and the absence of sperm. Each woman then had intercourse using either no film (baseline cycles) or a test film (test cycles) and returned 2-3 h afterwards. Cervical mucus was again assessed for adequacy and the presence of sperm. Each woman also underwent colposcopy, using a protocol developed by the World Health Organization. The average number of progressively motile sperm seen per high power field was as follows: first baseline cycle, 22.2; second baseline cycle, 22.1; test cycle with film containing 19 mg BZK, 0.2; test cycle with film containing 25 mg BZK, 0.0; and test cycle with VCF containing 70 mg N-9, 0.0. There was no significant difference between baseline cycles or among test cycles in the average number of progressively motile sperm seen (p = 0.78 and p > or = 0.75, respectively). The average number of progressively motile sperm seen in each test cycle did, however, differ significantly from the average number seen in either baseline cycle (p < 0.01). Colposcopy showed superficial de-epithelialization without underlying inflammation in 15-20% of baseline cycles, regardless of whether colposcopy was done before or after coitus; in 50% of cycles in which either dose of BZK was used; and in 69% of cycles in which VCF was used. In all cases women were asymptomatic. Erythema and petechiae were also seen on colposcopy although at a lower frequency than de-epithelialization. There was no difference in the acceptability of the films. A vaginal contraceptive containing either 19 or 25 mg BZK in a new film base appears to be comparable with VCF in preventing sperm from entering midcycle cervical mucus and may be somewhat less disruptive to the vaginal epithelium.

Administration, Intravaginal↗
PubMed1997

A phase I comparative study of three contraceptive vaginal films containing nonoxynol-9. Postcoital testing and colposcopy.

The objectives of this study were 1) to assess the ability of a new contraceptive vaginal film containing two doses of nonoxynol-9 (N-9) to prevent the penetration of sperm into midcycle cervical mucus, and 2) to determine the effect of the film on the vaginal epithelium. The novel formulation was compared with VCF (a currently marketed film also containing N-9). Ten women underwent two baseline cycles of postcoital testing in which no film was used, followed by three test cycles in which Allendale-N9 film, a new film containing either 100 or 130 mg N-9, or VCF containing 70mg N-9 was used. The sequence of testing cycles was randomized. In each cycle, condoms were used prior to midcycle, then a midcycle cervical mucus specimen was examined to ensure midcycle characteristics and the absence of sperm. Each woman then had intercourse using either no film (baseline cycles) or a test film (test cycles) and returned 2-3 h afterwards. Cervical mucus was again assessed for adequacy and the presence of sperm. Each woman also underwent colposcopy using a protocol developed by the World Health Organization. The average number of progressively motile sperm seen per high power field were as follows: average of the two baseline cycles, 19.3; test cycle with Allendale-N9 film containing 100 mg N-9, 0.6; test cycle with Allendale-N9 film containing 130 mg N-9, 0.9; and test cycle with VCF, 0.5. There was no significant difference between baseline cycles or between test cycles in the number of progressively motile sperm per high power field (HPF) seen (p = 0.31 and p > or = 0.50, respectively). The average number of motile sperm seen in each test cycle did, however, differ significantly from the number in either baseline cycle (p < 0.02). The majority of colposcopic examinations were normal. In one baseline cycle and eight test cycles, colposcopy showed superficial de-epithelialization without underlying inflammation. There was no apparent dose response and in all cases the volunteers were asymptomatic. A vaginal contraceptive containing either 100 or 130 mg N-9 in a new film base appears to be safe and comparable to VCF in preventing sperm from entering midcycle cervical mucus.

Administration, Intravaginal↗
PubMed2001

IVF-patients with nonmale factor "to ICSI" or "not to ICSI" that is the question?

PURPOSE: Intracytoplasmic sperm injection (ICSI) guarantees high fertilization rates and could theoretically lead to higher implantation rates as well. Furthermore injection into oocyte creates a hole in the zona pellucida similar to the procedure of assisted hatching. We were therefore interested to assess such a potential benefit for infertile IVF patients without male factor. MATERIALS AND METHODS: Open randomized prospective study according to the rules "Good Clinical Practice" with informed consent of the patients and institutional review board approval. Ninety-one consecutively seen patients with tubal infertility or hostile cervical mucus were randomized to undergo either ICSI (44 patients) or IVF (45 patients). In two patients fertilization of oocytes failed and so a repeated ICSI had to be performed. All these patients were stimulated with the same protocol, using the gonadotropin releasing hormone-agonist (GnRH-a) buserelin acetate in an ultrashort flair-up protocol together with pure follicle stimulating hormone (rFSH). The two study groups did not differ in terms of age, BMI, and all baseline hormone levels. RESULTS: The total pregnancy rate was 42% in the normal IVF group with 33% ongoing pregnancies. The ICSI group had a total pregnancy rate of 39% with 23% ongoing pregnancies. The implantation rate per transferred embryo was higher for normal IVF but not significant (18% versus 11%). The variables, fertilization rate, age, body mass index, baseline hormone levels, endometrial thickness, embryo score, and the highest grade embryo per transfer were very similar in both groups. CONCLUSION: ICSI should be applied only when conventional IVF fails, that is, for male factor patients and for patients with unexplained infertility.

Adult↗
PubMed1990

[Ovarian cysts in cattle--etiology, therapy success, fertility].

The functions of the ovaries were controlled in 92 cattle over a period of 12 to 95 days p.p. Cystic follicles developed in 61% (25 from 41) during reconvalescence period and were correlated with a 4.2 days earlier onset of ovarian function, which was assured statistically. All together in 41 animals cystic degeneration was registered. Cysts having appeared before day 39 p.p. receded spontaneously in 24%, those having developed later remained. By application of the GnRH-analogous Buserelin (Receptal), either exclusive or combined with beta-carotene or Prostaglandin Trometamol-Tiaprost (Iliren) ovarian function could be restored in all cases. Restitution was most rapid when using Buserelin plus beta-carotene (Fertilizing insemination 3 weeks post application), but protracted after the consecutive method of therapy. All 92 cattle became pregnant. The P4-level of all "cyst-cows" were low, i.e. between 0.68 and 0.81 ng/ml of skimmed milk. The increase of conductivity of the cervical mucus to above 30 Ohm turned out an evidence of an ovarian cyst to be present. Restoration took longer in correlation with the increasing diameter of the cysts.

Animals↗
PubMed1972

Clinical and laboratory findings in a trial of norgestrel, a low-dose progestogen-only contraceptive.

Norgestrel, a progestogen-only oral contraceptive, was given continually at a dose of 75 mug/day to 144 women of proved fertility. It was an efficient contraceptive with a failure rate of 2.1% (assessed by the "life-table" method) within the first 12 cycles and 3.6% within the first 30 cycles (or 2.0 conceptions per 100 woman-years when assessed by the Pearl index). The overall conception rate for the entire trial period was 2.1% and 1.3 pregnancies per 100 woman-years respectively. Norgestrel caused a high proportion of irregular and generally short bleeding intervals, about one-fifth of the cycles lasting less than 17 days. This irregularity appeared to be due to individual variance in cycle length between women rather than that between their successive cycles. No confirmed instances of thromboembolism were observed. Norgestrel apparently exerts its contraceptive action by several mechanisms: reduction in the sperm penetrability of the cervical mucus and an impairment of luteal function appear important. The serum concentrations of cholesterol and globulin were significantly reduced in women taking norgestrel. Preliminary observations suggest that on discontinuing the medication fertility is promptly restored. Of the 144 women originally enrolled 57 (40%) withdrew for reasons connected with the method before completing 30 months on trial, over half of them because of the irregular menstrual pattern. Nonetheless, in view of its main clinical and laboratory characteristics and simple mode of administration, norgestrel appears to be a useful alternative to the combined type of pill for women unsuitable for, or unable to tolerate, oestrogen-containing preparations.

Blood Chemical Analysis↗
PubMed1988

Natural methods for fertility control: a prospective study--First Part.

This study describes 4 years of verification of effectiveness and applicability of BBT and symptothermal methods. The couples chosen had to undergo a 6-month-long study phase, and be psychologically motivated and well trained in NFP. During this period, particular emphasis was given to the motivational factor, which was expanded in its anthropological, relational, pedagogical and, sometimes, moral contents. Four hundred and sixty couples entered the program, for a total of 8,140 cycles, in which BBT, cervical mucus, and intercourse were charted. The Pearl Index for unplanted pregnancies was 3.6. Twenty-five unplanned pregnancies occurred in couples using NFP for spacing, and no pregnancies were reported in limiters.

Adult↗
PubMed1979

The variation of the mean spinability of human cervical mucus throughout the various stages of reproductive life. Automatic measurement and statistical study.

The evolution of the mean spinability value of human cervical mucus was studied by means of an automatic device throughout the menstrual cycle and pregnancy and during and after the onset of menopause. The automatic measurement brings to light the major drawbacks presented by manual methods: values previously obtained should be considered as underestimated. The mean spinability value recorded from cyclic mucus exhibits a very significant increase at mid-cycle. Graphical analysis demonstrates that only small differences in the mean spinability value occur as pregnancy proceeds. A progressive and regular decrease in the mean spinability value can be recorded from the very beginning of the menopause. However, the spinability values observed in premenopausal mucus are noticeably higher than those recorded after the onset of the menopause. The numeric data furnished by the automatic measurement are discussed in terms of statistics.

Cervix Mucus↗
PubMed1999

Spectrophotometric analysis of molecular transport in gels.

An automated spectrophotometric method has been developed for analyzing molecular transport out from and into gels. A Beckman DU7500 diode-array UV-visible spectrophotometer with gel scanner was modified to accept and longitudinally scan a quartz diffusion cell, 0.3x10x40 mm. Molecules of interest are identified and concentrations quantitated via analysis of spectrophotometric absorbance peaks relative to background absorbance of the gel. Thus, concentration profiles are obtained as functions of both position and time. Test data are fitted to a diffusion model via nonlinear least-squares regression. Precision and accuracy of the method were assessed via analysis of several test molecules and gels: (1) 30 mg/ml nonoxynol-9 (N9), contained in 1% sodium alginate gel cross-linked with 2.5 mM calcium chloride, permeating standardized, reconstituted bovine cervical mucus (BCM); (2) 2.5 mg/ml sodium fluorescein, contained in and permeating 10 mg/ml and 100 mg/ml gelatin gels; and (3) 1.0 mg/ml sodium ganciclovir, contained in and permeating 10 mg/ml sodium hyaluronate gel. Diffusion coefficients for (1) and (3) were 3.8x10-7 and 54.1x10-7 cm2/s, respectively. All measurements of diffusion coefficients, partition coefficients, and solute loads obtained in this study were highly repeatable (most C.V.'s<8%). The mean diffusion coefficient for (2) was within 3% of values predicted from theory for the 100 mg/ml gel; the mean partition coefficient for (3) was within 2% of the expected value. This new technique is simpler than many traditional ones in that it does not require labeling of test molecules nor changes in refractive index of target materials. It is particularly well-suited to situations in which the target material is a gel, because no stirring of the target is necessary.

Alginates↗
PubMed1978

Antibodies to spermatozoa. VIII. Correlation of sperm antibody activity with postcoital tests in infertile couples.

A study of the correlation between results of postcoital tests (PCTs) and presence of sperm antibodies in sera of either male or female partners or in the cervical mucus of seminal plasma, was made in 127 infertile couples. The percentage of positive antibody tests increased progressively as PCT results deteriorated from excellent to poor. Thus, the percentage of positive serum tests, by either method used, was 7% in the excellent group as compared to 52% in the poor group. This progressive increase was evident only in the females; the antibody tests in the males did not correlate directly with the PCT results. Nonetheless, even with excellent PCT results, 7% of women and 21% of men showed presence of antibodies. On the other hand, in the group showing poor PCTs, 48% of women had an absence of antibodies.

Adult↗
PubMed2005

Cervical mucus secretions on the day of intercourse: an accurate marker of highly fertile days.

OBJECTIVE: To provide estimates of the probabilities of conception according to vulvar mucus observations classified by the woman on the day of intercourse. STUDY DESIGN: Prospective cohort study of 193 outwardly healthy Italian women using the Billings Ovulation Method. Outcome measures include 161 conception cycles and 2594 non-conception cycles with daily records of the type of mucus and the occurrences of sexual intercourse. RESULTS: The probability of conception ranged from 0.003 for days with no noticeable secretions to 0.29 for days with most fertile-type mucus detected by the woman. The probability of most fertile type mucus by day of the menstrual cycle increased from values <20% outside of days 10-17 to a peak of 59% on day 13. CONCLUSION: Regardless of the timing of intercourse in the menstrual cycle, the probability of conception is essentially 0 on days with no secretions. This probability increases dramatically to near 30% on days with most fertile-type mucus, an association that accurately predicts both the timing of the fertile interval and the day-specific conception probabilities across the menstrual cycle.

Cervix Mucus↗
PubMed1979

A surgical technique for the collection of cervical mucus in the ewe.

A technique for collecting cervical mucus in ewes is described. By a surgical procedure, the cervix was fixed to the ventral abdominal wall to enable mucus to be collected continuously into a container attached to the ewe. Mucus was collected successfully by this method for up to 14 months.

Abdominal Muscles↗
PubMed1976

Cervical bacterial flora in women fitted with a copper-releasing intra-uterine contraceptive device (IUD).

A bacterial culture was taken from the cervix in 85 sexually active women before, and 3 and 6 months after, insertion of either a copper-releasing or an inert intra-uterine contraceptive device (IUD). Sixty had a Copper-T (TCu-200) and 25 a Lippes loop D. Although in more than a quarter of the patients the bacterial flora increased slightly in diversity and abundance after IUD insertion, there was no difference in effect between the TCu-200 and Lippes loop D.

Adult↗
PubMed1990

[Prediction of ovulation].

Prediction of ovulation was carried out by B-ultrasonography, BBT graph, cervical mucus and appearance of mittelschmerz in 45 normally menstruation women for a total of 72 cycles. LH peak values were also determined in 20 cases (20 cycles). The results were as follows: 1. The relation-ship between each index and ovulation: (1) The ultrasound image of follicle: average daily follicular growth during the 4-5 day before ovulation was 2.5 +/- 2.1 mm (means +/- s). Average diameter of the biggest follicles one day before ovulation was 20.6 +/- 2.0 mm. (2) The change of cervical mucus: the opening of external os and the secretion of mucus with ferning became most typical one day before the ovulation. (3) BBT graph: in a majority of cycles, ovulation occurred at the first day of the initial rise in temperature. (4) Mittelschmerz: occurred in 35% of cycles and appeared within 24 hours before ovulation. (5) LH peak value: ovulation occurred 24 to 48 hours after the first significant rise of LH, and within 24 hours after LH peak value. 2. The relation-ship between indices: in the majority of cases, when we employ the ultrasound image of follicular rupture as a signs of ovulation, LH peak value, follicle of biggest diameter, maximum volume of cervical mucus, the lowest point of BBT and mittelschmerz appear on the same day, namely, one day before ovulation. The authors suggest that ultrasonography used combination with other parameters provides a feasible and relatively accurate and reliable method for the prediction of ovulation in clinical practice.

Adult↗