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PubMed1986

Longevity of Gynol II and Ortho Creme in the Prentif cervical cap.

A review of the literature yielded no scientific basis for current recommendations on the length of time spermicide-filled cervical caps can be worn while continuing to protect against pregnancy. Ten cervical cap users provided 99 samples of cap contents after a variety of insertion periods using Gynol II, Ortho Creme and vehicle controls. Testing for spermicidal effect was performed in the laboratory using quality semen from two donors and employing the Multiple Exposure Photography system of semen analysis. Criteria for determining spermicide effectiveness were developed. Results suggest that 3 to 4 days is the reasonable limit for cap use with Gynol II and 5 days with Ortho Creme, contrasted with 1 day limits for Gynol II and 2 day limits for Ortho Creme using existing criteria. Limited experience with samples exposed to semen in vivo suggest that spermicidal potency is not lost through repeated intercourse. Recommendations for validating these limits with clinical studies are made.

Adult↗
PubMed1986

Contraception with the cervical cap: effectiveness, safety, continuity of use, and user satisfaction.

With the growing interest in barrier contraceptive methods, the cervical cap has come back into use in North America. We examined the cap's effectiveness, safety, continuity of use, and user satisfaction among 617 women who were fitted at a family planning clinic in Toronto, Canada, between May 1981 and November 1983. Follow-up information was available for 516 of these women. Using a life table analysis with Bayesian adjustment, the probability of becoming pregnant after 12 months of use was 0.166 with a standard error of 0.022. There is evidence that after 1 year of use the caps deteriorate and that this deterioration may increase the risk of pregnancy. Many of the women in this study were very satisfied with the cervical cap; however, such problems as dislodgement, discomfort to user and partner, difficulty with insertion and removal, and unpleasant odour affected acceptability and continuity of use. It is likely that these problems could be alleviated by improving the quality of or changing the materials, modifying the design to improve the fit, and providing a greater range of sizes.

Adolescent↗
PubMed1986

Cervical tissue uptake of all-trans-retinoic acid delivered via a collagen sponge-cervical cap delivery device in patients with cervical dysplasia.

The present study was undertaken to evaluate the systemic absorption and cervical tissue uptake of all-trans-retinoic acid (TRA), delivered via a collagen spongecervical cap delivery device in patients with intraepithelial cervical dysplasia. Ten patients with histologically proven mild or moderate cervical dysplasia were included in this pharmacologic study. The two TRA concentrations (0.05% and 0.372%) selected for study represent the starting and maximally tolerated doses used in phase I clinical trial. All-trans-retinoic-11-3H acid (3H-TRA, 500 mu Ci) was used to facilitate cervical tissue uptake studies. Cervical biopsies and post-treatment blood samples were obtained from each patient after TRA exposure. The uptake of TRA into cervical tissues four hours after drug administration was significantly increased at the maximally tolerated TRA dose. There was a rapid decrease in cervical tissue concentration of TRA at the 0.372% dose between 4 and 24 h after drug exposure, suggesting a relatively short elimination half-life of TRA in cervical tissues. HPLC analysis of post-treatment blood samples indicate that there was no systemic absorption of TRA after local cervical administration.

Administration, Topical↗
PubMed1982

The Prentif contraceptive cervical cap: a contemporary study of its clinical safety and effectiveness.

Because they seemed to be an overlooked, underutilized, and underdeveloped means of contraception, cervical caps were offered to patients in a private gynecological practice and the first 413 acceptors were sent a detailed questionnaire about their experiences. The 371 who responded provided generous amounts of information helpful in assessing not only cap safety and effectiveness, which are dealt with herein, but also in assessing acceptability which is dealt with in the companion article that follows. With regard to safety considerations, "cervical erosion" was not found to contraindicate cap use and no other significant safety hazards were encountered, although two concerns were suggested for further evaluation. The failure rate was 8.4 per 100 women per year by the life table method. Of 25 failures, 11 were labeled method failures and 14 were labeled human failures by the respondents themselves. The role of cap dislodgement as a cause of method failures is analyzed. It is concluded that caps are as safe and effective as diaphragms and that for many women they are the most suitable form of contraception available. It is reasonable to expect that they will soon be able to be approved for general use.

Adult↗
PubMed1982

The Prentif contraceptive cervical cap: acceptability aspects and their implications for future cap design.

Patients in a private gynecological practice were offered the Prentif contraceptive cervical cap. The first 413 acceptors were sent a questionnaire covering in detail many of the aspects of their experience. The 371 responses contained a wealth of information concerned with safety, effectiveness and acceptability. Safety and effectiveness are dealt with in the companion article preceding, while the less serious risk factors that reduce the acceptability of the Prentif cap are presented and discussed herein. In order of descending frequency, these factors include: odor; difficulty removing; discomfort to partner; difficulty inserting; dislike of spermicide; discomfort to self; urinary discomforts; vaginal infections; vaginal discharge; and vaginal itching. The most attractive features of the cap, as compared with the diaphragm, were: increased convenience; greater safety; less interference with spontaneity; increased frequency of intercourse; and increased libido. Despite multiple problems with Prentif caps, 67.4% of the cap recipients were still using their caps after one year. However, this was among a select group of highly motivated women of above-average intelligence. The causes of cap acceptability problems are discussed along with probable future improvements in cap design that may solve them.

Adult↗
PubMed1984

Use effectiveness of the Prentif cervical cap in private practice: a prospective study.

Of two-hundred-sixty women seeking cervical cap contraception, exactly half subsequently used the Prentif cavity rim cap as their sole method of contraception. The one year continuation rate for these exclusive cap users was 56.7 per hundred. No major side effects related to the use of the Prentif cap were observed in the course of this study, involving 918 women-months in year 1. Pregnancy and dislodgement of the cap during use were the principal reasons for discontinuation of exclusive use, with gross rates of 19.1 and 12.9 per 100 at one year, respectively.

Adult↗
PubMedDate not supplied

[Adaptation of a cervical cap for human artificial insemination].

The authors have designed a cervical cap in plastic throught which artificial insemination can be practised. The material allows prolonged contact between semen and the cervical mucus. Tests carried out 24 hours after insemination have shown that after 159 inseminations there were mobile spermatozoa in the mucus in 145 cases.

Female↗
PubMed1984

The cervical cap: a retrospective study of an alternative contraceptive technique.

A follow-up study on 130 women fitted with a cervical cap over a 12-month period drew a response rate of 43% (56 respondents). The group was young, well educated, and highly motivated. The failure rate was 16.9 per 100 women years (Pearl method), with inconsistent use and dislodgement being of major importance. The continuation rate was 75% (minimum 3 months of use), and 84% expressed satisfaction with the method. No significant side effects or risks to health were encountered. The conclusion is that there is a significant demand for alternative contraceptive methods among a select group of women. However, in the present state of knowledge, use of the cap should probably not be encouraged as a primary means of contraception, but should be reserved for those women with multiple contraceptive problems or for highly motivated women who seek out this means, understand its limitations, and can accept the relative uncertainty of its effectiveness.

Adult↗
PubMed1996

Randomized controlled trial of cervical cap with intracervical reservoir versus standard intracervical injection to inseminate cryopreserved donor semen.

A prospective controlled study of donor insemination without sperm preparation or ovarian stimulation was performed to compare the use of a cervical cap incorporating an intracervical reservoir with a standard intracervical injection technique to inseminate 0.5 ml cryopreserved semen. Treatments were alternated in successive cycles in each patient after initial randomized selection. A total of 198 patients had 635 treatment cycles (median 3, range 1-7), 309 with reservoir and 326 by standard injection. A total of 56 women became pregnant, 24 (7.8% per cycle) with the reservoir and 32 (9.8% per cycle) by injection. There were no significant differences between the pregnancy rates per cycle overall or cycle-specific cumulative rates calculated using the life-table method. There were no significant differences in age, parity, baseline gonadotrophin measurements, mid-luteal serum progesterone concentrations, frequency of adverse fertility factors in the woman or her partner's cause of infertility between women who conceived and those who failed to conceive. We conclude that use of a cervical reservoir and cap for donor insemination does not offer any advantage over standard intracervical insemination.

Adult↗
PubMed1989

Effectiveness of the cavity-rim cervical cap: results of a large clinical study.

From 1981-1988, 3433 women were fitted with a cavity-rim cervical cap in a Food and Drug Administration-approved study. The estimated first-year pregnancy risk was 11.3% (95% confidence limits 10.0-12.8), with risks of 8.3 and 3.8% for user and method failures, respectively. Women who were younger, less educated, and more sexually active, and who intended to have children in the future, had higher pregnancy risks. "Near-perfect" users, ie, individuals who wore the cap for a maximum of 72 hours, used spermicide 100% of the time, and did not report unprotected sexual intercourse, had half the first-year pregnancy risk of others (6.1 versus 11.9%). There were no serious medical or gynecologic complications associated with cap use, although over 20% of users reported problems with cap dislodgment during or after intercourse, cap malodor, or partner discomfort.

Adult↗
PubMedDate not supplied

Cervical cap homologous artificial insemination (AIH): the University of Florence experience.

We report our experience with artificial insemination with husband's semen (AIH) using cervical cap. Forty-four couples were admitted to our AIH program over a two-year period. In 4 couples, AIH was performed due to impotence or hypospadia, while in the remaining 40 couples indications for AIH were abnormal semen, poor post-coital test, anti-sperm antibodies, poor cervical mucus. Overall, six pregnancies were obtained (pregnancy rate = 15%) in the latter group; in particular, AIH was able to elicit pregnancy in 5 out of the 25 cases of abnormal semen (20%). Our data emphasize the importance of female factors associated with infertility since significantly higher pregnancy rates (45.4% versus 0%) were observed in subjects in whom these factors were absent.

Adult↗
PubMed1989

The Prentif cervical cap and Pap smear results: a critical appraisal.

An analysis from a randomized study has suggested that a larger percentage of Class III Pap smears appears among Prentif cervical cap users three months after initiation of use of the method than among diaphragm users. This suggestion has been the basis of a U.S. Food and Drug Administration (FDA) requirement that women seeking to use the cap have Pap smears taken before initiating use and again after three months of use. The data from the pivotal randomized study are reanalyzed here. No significant differences exist in the distributions of smears between cap and diaphragm users at three months or throughout the first year. The majority of cap users with "Class III" smears at three months did not have even mild dysplasia when subsequently evaluated by biopsy or colposcopy. This was also the case for diaphragm users classified as having grade III smears at three months. Other studies of the Prentif cap have not found conversions to Class III smears at one year. The requirement of a 3-month Pap smear is not only economically burdensome to potential users of the cap but appears to be without firm foundation in the original data or in our current views of cervical carcinogenesis.

Adult↗
PubMed1982

Artificial insemination with fresh donor semen using the cervical cap technique: a review of 278 cases.

Two hundred twenty-six patients received artificial insemination with fresh donor semen (AID) using the cervical cap technique; 52 patients underwent the procedure for 2 conceptions. Using life-table analysis to adjust for uneven patient follow-up, the cumulative pregnancy rate was 62.5% after 6 months of AID, and 82.4% after 10 months. Moreover, using a mathematical model of cumulative pregnancy following AID, the estimated cure rate was not significantly different from 100%, and the estimated monthly probability of pregnancy among those cured was 15.5%. Age was found to be inversely related to pregnancy success, while parity had no effect. For those who continued to undergo AID beyond 6 months, the monthly probability of pregnancy did not decline. Patients can be advised that their chance of conception with AID should approach that of normal fertile couples.

Adult↗
PubMed1986

Phase II trial of beta-all-trans-retinoic acid for cervical intraepithelial neoplasia delivered via a collagen sponge and cervical cap.

Retinoids are effective suppressors of the phenotypic development of cancer in many animal systems, whether the process is initiated by chemical, physical or viral carcinogens. Cases of cervical intraepithelial neoplasia are excellent for studying the effectiveness of retinoids as chemopreventive agents because the process can be closely followed by serial colposcopic and pathologic (cytology or biopsy) means and changes in the condition safely monitored. We have previously conducted a phase I study of trans-retinoic acid (Tretinoin) given topically by a collagen sponge and cervical cap. A dose of 0.372% was selected for phase II trial. We have treated 20 patients with topical retinoic acid, and a complete response with total regression of disease was obtained in 50%. Systemic and cervical side effects were mild and vaginal side effects moderate but tolerable. These results provide a clinical basis for a randomized, double-blind phase III study to definitely answer the question of whether retinoic acid is an effective chemopreventive agent for cervical cancer.

Animals↗
PubMed1988

The cervical cap.

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Cervix Uteri↗