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PubMed1990

Transport of novel ovum surrogates in the human fallopian tube: a clinical study.

Functional inadequacy of the fallopian tube cannot be adequately diagnosed by classical tubal patency tests. A new method using novel ova surrogates, microspheres transport test, is designed to diagnose dysfunctional tubal sterility. Biodegradable test microspheres with diameters matching that of the native ovum were used. According to the optimum procedure, the suspension of test microspheres was applied through the vaginal wall into the Douglas' space under local anesthesia, and the transported microspheres were collected in a modified cervical cap. The microspheres were readily identified in the sediment of cervical secretion by their fluorescence. The method was tested in 139 long-term infertility patients. Transport was observed in 100% of the control group, and positive correlation between the transport findings and the anticipated frequencies of dysfunctional tubal sterility cases in other groups was found. Optimum diameter of test microspheres was estimated at about 175 microns. The test appears to be useful for examination of functional disorders of the ovum transport in human practice.

Adult↗
PubMedDate not supplied

Women's barrier contraceptive methods: poised for change.

Over the past 20 years, the number of women in the United States choosing a cervical barrier contraceptive method has dramatically declined. By 2002, fewer than 3% of women reported using any woman-initiated barrier method, including the diaphragm, female condom, or cervical cap. At the same time, however, research in infectious diseases indicates that cervical barriers may effectively prevent the transmission of several sexually transmitted infection. This possibility has fueled the recent development of two novel devices. This article examines the seven devices currently available in the United States, comparing their characteristics, efficacy, benefits, and drawbacks. Compared to the diaphragm, the new devices do not offer improved odds of pregnancy prevention, and evidence for their efficacy is sparse. Reasons for the limited acceptance of these methods as contraceptives on one hand-and for interest in their potential for limiting sexually transmitted infections on the other-will also be reviewed. Despite the limited acceptance of cervical barrier methods, midwives and other clinicians should promote their availability as an alternative to other reversible contraceptives.

Contraception, Barrier↗
PubMed1986

Contraception and the cervix.

In the human and subhuman primates the uterine cervix plays an important role in the reproductive process by its permissive and inhibitory action on sperm migration from the vaginal pool into the cervical canal, the uterine cavity and the fallopian tube, the site of gamete unification and fertilization. This is accomplished through physico-chemical (amount, clarity, viscosity, pH, electrolyte composition, etc.) alteration of the cervical mucus in response to the circulating sex steroids. In an ovulatory cycle, shortly prior to and at the time of ovulation the cervical mucus becomes most receptive to the spermatozoa whereas at other times, specifically following ovulation, it becomes hostile to the spermatozoa and virtually impenetrable. This unique property of the cervical mucus may, in addition to the presently available techniques (diaphragm, cervical cap and intracervical devices), allow identification of such potential contraceptive modalities as: pH modifier - changing the pH of the cervical mucus from alkaline to acid around the time of ovulation; Electrolyte modifier - changing electrolyte composition of the cervical mucus to produce a mesh impenetrable to spermatozoa. Finally, development of a temporary localized tissue-fixed immune antibody to spermatozoa in the cervical mucus is within the realm of reality and deserves the necessary attention.

Animals↗
PubMed1983

Effect of cervical application of prostaglandin (PG) E2 on plasma 13,14-dihydro-15-keto-PGF2 alpha and oxytocin in pregnant women at term.

The concentrations of 13,14-dihydro-15-keto-prostaglandin F2 alpha (PGFM) and oxytocin were measured by radioimmunoassay in the peripheral plasma of 21 women with low Bishop scores in whom cervical ripening and labour were induced with a cervical cap containing 1.5 mg of prostaglandin (PG) E2, left in place for 6 h. Blood samples were taken before and at 3, 6, 9 and 24 h after the cap was applied. Four women (control group) had a cap without PGE2. Labour began in 13 women receiving PGE2, 12 of whom were delivered within 24 h. In these women plasma PGFM rose progressively to levels seen during spontaneous labour, paralleling the changes in cervical dilatation. The increase became significant at 6 h, when cervical dilatation was 4.5 cm (SEM 0.5). Plasma oxytocin also increased significantly while the cap was in place and then decreased. Plasma PGFM and oxytocin did not change in the control subjects, and in the eight women needing further induction of labour the initial rises were transient and not statistically significant.

Cervix Uteri↗
PubMed1979

The use of donor mucus and insemination for cervical factor.

In a case of infertility due to cervical factor, application of donor mucus into the cervical canal was effective. The donor mucus with the first fraction of the husband's split ejaculate were incubated at 37 degrees C for 20 minutes. The mucus was then introduced into the cervical canal and a cervical cap for insemination was applied. A positive postcoital test was demonstrated after 6 hours. The patient conceived following a second such treatment. Donor cervical mucus aplication and insemination seem to be of value in the treatment of cervical factor.

Adult↗
PubMed1986

Clinical experience with topical tretinoin in the treatment of cervical dysplasia.

Dysplasia of the uterine cervix is a recognized preneoplastic condition. Because of the observed ability of retinoids to reverse other dysplastic conditions in vitro and in vivo, a number of clinical studies have been carried out of the effect of these agents on cervical dysplasia, with the object of developing a means of chemoprevention of cervical malignancies in women at risk. We have conducted phase I and II trials of topical tretinoin (retinoic acid and Retin-A) delivered by means of a cervical cap and inert collagen sponge system. The results of these studies warranted a phase III trial, which is now underway. The outcome of the latter investigation will have important implications, not only for the management of patients with cervical dysplasia but also for therapeutic approaches to other precancerous conditions.

Administration, Topical↗
PubMed1999

5-aminolevulinic acid-mediated photodynamic therapy of intraepithelial neoplasia and human papillomavirus of the uterine cervix--a new experimental approach.

The aim of this study was to treat patients for ectocervical dysplasia [cervical intraepithelial neoplasia (CIN) grades 1 and 2] and associated human papilloma virus (HPV) infections with photodynamic therapy (PDT). In 20 patients, 5-aminolevulinic acid (5-ALA, 12% w/v) was applied topically with a cervical cap 8 h prior to illumination. A thermal light source (150 W halogen lamp) emitting a broadband red light (total energy: 100 J/cm2, fluence rate: 90 mW/cm2) was used for superficial illumination of the portio. In addition, an Nd:YAG pumped dye laser (652 nm) was used to illuminate the cervical canal (total energy: 50 J/cm2, fluence rate: 300 mW/cm2). Preliminary results of follow-ups at 1, 3, 6, and 9 months posttherapy showed a cytological improvement in the grading of the PAP smears in 19 patients and the eradication of cervical HPV in 80%. These results demonstrate that ectocervical dysplasia and associated HPV infections can be treated by PDT.

Administration, Intravaginal↗
PubMed1996

Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide.

The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.

Adult↗
PubMed1995

Contraceptive methods and the risk of Chlamydia trachomatis infection in young women.

To evaluate the relation between contraceptive methods and cervical Chlamydia trachomatis infection, the authors studied a population-based sample of 1,779 nonpregnant women aged 15-34 years who underwent cell culture diagnostic testing for the detection of C. trachomatis at a health maintenance organization. Barrier contraceptive method users were classified as those who reported using one of the following methods at time of testing: condom, diaphragm, cervical cap, spermicidal sponge, foam, or vaginal spermicidal suppositories. Barrier methods were associated with a reduction in the risk of chlamydial infection in women aged 25 years or older when compared with all other women in the same age category (adjusted prevalence odds ratio = 0.15, 95% confidence interval (CI) 0.04-0.66). When compared with only noncontracepting women, the adjusted prevalence odds ratio was 0.34 (95% CI 0.06-1.99). The protective effect of barrier methods was not evident in women younger than age 25 years. Oral contraceptive use was not associated with the risk of C. trachomatis infection using either referent group; the adjusted prevalence odds ratio was 0.99 (95% CI 0.57-1.73) compared with all other women, and 0.88 (95% CI 0.44-1.79) compared with noncontracepting women. These findings suggest that present patterns of use of barrier methods differ by age and afford only selective protection against cervical C. trachomatis infections.

Adolescent↗
PubMed1986

A phase I trial of topically applied trans-retinoic acid in cervical dysplasia-clinical efficacy.

Forty-two patients were entered into a phase I trial to evaluate the vitamin A derivative, trans-retinoic acid, in cervical intraepithelial neoplasia. Treatment consisted of four consecutive 24-h applications of retinoids via an inert collagen sponge in a cervical cap. Patients were followed for response at 3-month intervals using cytology, colposcopy, and selected biopsies. Thirty-six patients were evaluable (mild dysplasia, 13; moderate dysplasia, 17; severe dysplasia, 6) with follow-up from 5 to 18 months. Complete regression was seen in 2/14 (14%) patients treated with concentrations of 0.05%----0.1167% and in 10/22 (45%) patients treated with concentrations of 0.1583%----0.484% (p less than 0.05). One patient with negative biopsies at 12 months has subsequently recurred at 18 months.

Administration, Topical↗
PubMed2002

Photodynamic therapy of high-grade cervical intraepithelial neoplasia with 5-aminolevulinic acid.

BACKGROUND AND OBJECTIVES: To determine the safety and efficacy of 5-aminolevulinic acid (ALA) as a topically applied photosensitizer for photodynamic therapy (PDT) of cervical intraepithelial neoplasia (CIN). STUDY DESIGNS/MATERIALS AND METHODS: Forty women, who were at least 18 years old with persistent biopsy-proven CIN 2 and CIN 3 within the previous 3 months of enrollment, underwent PDT in a phase I and II design. Five escalating radiant energies (increments of 25 J/cm(2), beginning at 50-150 J/cm(2)) using a Coherent Dye Model 920 argon pumped dye laser providing light at 630 nm (maximum output 0.8 W) were used to perform PDT with a fixed dose of ALA (200 mg/ml). ALA was placed in a cervical cap fitted to the cervix. After 90 minutes, the cap was removed and the ectocervix was illuminated for 5-16 minutes, depending on the irradiance. Success was defined as the absence of CIN on Pap smear or colposcopic examination at 12-months. Patients were monitored for toxicity. RESULTS: Thirty-two women (80%) completed the study with 1 year of follow-up. Sixty percent had CIN 3 and 40% CIN 2. Success rates at 4, 8, and 12 months were 51, 46, and 31%, respectively, and were not light-dose dependent. Three patients progressed from CIN 2 to CIN 3. Toxicity was tolerable and only consisted of spotting, vaginal discharge, mild cramping, and vaginal warmth. There was no apparent dose relationship to toxicity. CONCLUSIONS: PDT at this light and ALA dose is well tolerated but has minimal activity in the treatment of CIN 2 and CIN 3. Other doses and schedules of light and ALA or novel photosensitizers may improve efficacy.

Adult↗
PubMed1999

Photodynamic therapy in women with cervical intraepithelial neoplasia using topically applied 5-aminolevulinic acid.

Photodynamic therapy (PDT) is a novel treatment modality that produces local tissue necrosis with laser light after prior administration of a photosensitizing agent. We performed a study of topically applied 5-aminolevulinic acid (5-ALA) in the photodynamic treatment of women with high-grade cervical intraepithelial neoplasia (CIN) using fixed 5-ALA doses and application protocols derived from previous in vitro and in vivo results. Three to 5 hr prior to PDT, 10 ml of a 20% solution of 5-ALA was topically applied using a cervical cap. PDT was performed with irradiation of 100 J/cm2 at an irradiance of 100-150 mW/cm2 with an argon-ion-pumped dye laser at 635 nm. For the endocervix, a specifically designed cylindrical applicator was used. Ten treatment cycles of PDT using 5-ALA were performed in 7 patients with high-grade CIN. Non-thermal laser treatment with 100-150 mW/cm2 was well tolerated. Local toxicity was minor as several patients reported burning sensations and vaginal discharge, but no necrosis, sloughing or scarring occurred. After 3 months, a significant reduction in the size of the ectocervical CIN lesions was noted in only 3 patients, who underwent a second PDT cycle. However, no significant improvement in CIN lesions was noted since cold knife conization revealed persistent CIN in all 7 cases. Therefore, PDT after topical application of 5-ALA using an irradiation of 100 J/cm2 produces only minimal side effects. However, it does not appear to be effective in treating CIN.

Administration, Topical↗
PubMed1998

Pharmacokinetics and selectivity of aminolevulinic acid-induced porphyrin synthesis in patients with cervical intra-epithelial neoplasia.

Photodynamic therapy (PDT), due to its tumor selectivity, represents an alternative approach to diagnose and treat cervical intra-epithelial neoplasia (CIN) without altering normal surrounding tissue. Our aim was to investigate the pharmacokinetics and the selectivity of 5-aminolevulinic acid (5-ALA)-induced porphyrin fluorescence after topical administration, to obtain basic clinical data for future diagnostic fluorescence imaging and PDT protocols for CIN. Twenty-eight non-pregnant women with a cytological diagnosis of low-grade or high-grade squamous intra-epithelial lesions were included. An aqueous solution containing 3% 5-ALA was topically applied 1 to 6 hrs prior to conization using a cervical cap. After excision, porphyrin-induced fluorescence was quantified in dysplastic (n = 14) and normal epithelium (n = 28) by means of quantitative fluorescence microscopy. High values of porphyrin fluorescence were found in squamous epithelium between 150 and 450 min, with a maximum at 300 min following administration of 5-ALA. Ratios of porphyrin fluorescence of dysplastic vs. surrounding normal epithelium were 1.3 and 1.21 for CIN 1 (n = 3) and CIN 2 (n = 3), respectively. In CIN 3 patients (n = 8), this ratio was 2.35; the best selectivity of 5-ALA-induced porphyrin fluorescence in CIN 3 lesions (ratio 3) was observed with a topical administration time of between 150 and 250 min. Our results demonstrate that patients with CIN 3 show higher 5-ALA-induced fluorescence compared with normal epithelium. The optimal administration time of topically applied 5-ALA was between 3 and 4 hr. Our data suggest that topical ALA-PDT and photodynamic diagnosis might be suitable for detecting CIN.

Adult↗
PubMed1981

Postpartum contraception.

Recently-delivered women who wish to avoid pregnancy should initiate contraception before ovulation. Since the return of ovulation is not predictable, regardless of the woman's lactation status and duration of postpartum amenorrhea, contraception should be initiated as soon as is reasonable after delivery. The choice of contraceptive method will depend on several factors, including: the woman's lactation status, the preference of the woman and her partner, and the health status of the newborns. For women who do not wish to have additional children, tubal sterilization through a minilaparotomy incision is the procedure of choice. For other women who are not lactating, all methods, with the exception of the use of cervical caps and diaphragms, may be initiated immediately after delivery. However, preference should be given to IUD use by lactating and non-lactating woman, especially for women who may not return for any additional postpartum care.

Contraception↗
PubMed1984

Vaginal contraception: an overview.

Some of the more recent advances in vaginal contraception (suppositories, diaphragms, cervical caps, contraceptive sponges) are reviewed, and, when available, data relating to their safety and effectiveness are presented.

Contraception↗
PubMed2005

Barrier and spermicidal contraceptives in adolescence.

This article describes both barrier and spermicide methods of contraception including the male and female condom, diaphragm, contraceptive sponge, Lea Shield, cervical cap and multiple spermicide options. Their efficacy, differences and proper use are discussed with an emphasis on the adolescent user.

Adolescent↗
PubMed1997

A phase I study of Femcap used with and without spermicide. Postcoital testing.

The objectives of the study were to assess the ability of the Femcap, a new vaginal contraceptive device made of silicone and designed to fit snugly around the cervix to prevent the penetration of sperm into midcycle cervical mucus when used with and without spermicide; and to compare it with the standard contraceptive diaphragm used with spermicide. Eight women underwent two baseline cycles of postcoital testing in which no device was used, followed by three test cycles in which Femcap with spermicide, Femcap with nonspermicidal lubricant (K'Y gel) or the Ortho All-Flex diaphragm with spermicide 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 device (baseline cycles) or the prescribed device (test cycles) and returned 2-3 h afterwards. Cervical mucus was again assessed for adequacy and the presence of spermatozoa. The average number of progressively motile sperm seen per high power field was as follows: first baseline cycle, 18.0; second baseline cycle, 17.8; test cycle with Femcap used with nonspermicidal lubricant, 0.1; test cycle with Femcap used with spermicide, 0.2; and test cycle with the diaphragm used with spermicide, 0.0. There was no significant difference between baseline cycles or among test cycles in the average number of progressively motile sperm seen (p > 0.05). 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 < 0.05). Femcap, used with either a spermicidal lubricant or a nonspermicidal lubricant, appears to be comparable with the diaphragm used with spermicide in preventing sperm from entering midcycle cervical mucus.

Cervix Mucus↗
PubMed1999

A comparative study of the safety and efficacy of FemCap, a new vaginal barrier contraceptive, and the Ortho All-Flex diaphragm. The FemCap Investigators' Group.

The FemCap is a new silicone rubber barrier contraceptive shaped like a sailor's hat, with a dome that covers the cervix, a rim that fits into the fornices, and a brim that conforms to the vaginal walls around the cervix. It was designed to result in fewer dislodgments and less pressure on the urethra than the cervical cap and diaphragm, respectively, and to require less clinician time for fitting. This was a phase II/III, multicenter, randomized, open-label, parallel group study of 841 women at risk for pregnancy. A subset of 42 women at one site underwent colposcopy. Women were randomized to use the FemCap or Ortho All-Flex contraceptive diaphragm, both with 2% nonoxynol-9 spermicide, for 28 weeks. The objectives were to compare the two devices with regard to their safety and acceptability and to determine whether the probability of pregnancy among FemCap users was no worse than that of the diaphragm (meaning not more than 6 percentage points higher). The 6-month Kaplan-Meier cumulative unadjusted typical use pregnancy probabilities were 13.5% among FemCap users and 7.9% among diaphragm users. The adjusted risk of pregnancy among FemCap users was 1.96 times that among diaphragm users, with an upper 95% confidence limit of 3.01. Clinical equivalence (noninferiority) of the FemCap compared with the diaphragm, as defined in this study, would mean that the true risk of pregnancy among FemCap users was no more than 1.73 times the pregnancy risk of diaphragm users. Because the observed upper 95% confidence limit (and even the point estimate) exceeded 1.73, the probability of pregnancy among FemCap users, compared with that among diaphragm users, did not meet the definition of clinical equivalence used in this study. The FemCap was believed to be safe and was associated with significantly fewer urinary tract infections. More women reported problems with the FemCap with regard to insertion, dislodgement, and especially removal, although their general assessments were positive. The two devices were comparable with regard to safety and acceptability, but a 6-point difference in the true 6-month pregnancy probabilities of the two devices could not be ruled out. Further studies are needed to determine whether design modifications can simplify insertion and removal.

Adolescent↗