Nadia M. Marchi

The effect upon the human vaginal histology of the long-term use of the injectable contraceptive Depo-Provera®☆

The objective of the study was to evaluate the effect of long-term use of the injectable contraceptive depot medroxyprogesterone acetate (DMPA) on human vaginal histology. Twenty premenopausal women currently using DMPA as a contraceptive method for two and three years were compared with 20 regularly menstruating women, who never used Depo-Provera and/or other kind of hormonal contraceptive in the last 6 months prior to the study. Subjects and controls were matched by age (+/-1 year), body mass index (kg/m2) (+/-1.0), number of pregnancies (+/-1), age at first intercourse (+/-1 year), years of sexual activity (+/-1 year), and number of partners during their life (+/-1). Vaginal biopsies were performed in users at 90+/-7 days after the last injection and in nonusers at day 20-25 of the menstrual cycle. In addition, at the day of the biopsy a blood sample was collected to measure estradiol (in all women) and DMPA in users. The level of serum estradiol was significant lower in Depo-Provera users than in controls (p < 0.001). The thickness of the vaginal epithelium was not smaller among DMPA users than among controls, the mean count of Langerhans cells per mm of epithelium were almost identical in both groups, and no significant differences were found on the vaginal maturation indices. In conclusion, the use of Depo-Provera between two and three years did not affect vaginal thinning of the epithelium, Langerhans cell count or maturation index.

Self-administration with UniJect® of the once-a-month injectable contraceptive Cyclofem®

The objective of this study was to evaluate womens acceptance of and ability to self-administrate the injectable contraceptive Cyclofem using prefilled UniJect devices. A total of 102 women were invited to participate in the study. Fourteen women (13.7%) refused to participate. Of the remaining 88 women, 32 women (31.4%) consented to participate and were trained using oranges but were still afraid of the procedure and ultimately refused to self-administer the injections. Only 56 women (55%) ultimately self-injected Cyclofem with UniJect. They performed a total of 144 injections, all of them on the ventral side of the thigh. When nurses evaluated womens ability to activate the devices, they found that more than 80% were successful in both the group of women that later self-administered the injections and the group that did not. The evaluation of the self-administered injection technique showed that more than 90% of the women correctly self-administered the contraceptive using UniJect. With respect to the opinion of the women about the self-administration of the contraceptive, more than 50% (32 of 56) of women who self-injected preferred to self-administer the injection and said that they wished to continue with the self-administration, one-third (17) reported that they were afraid, and seven women (12.5%) expressed the opinion that the injection in the thigh was more painful than the administration in the buttocks or arm. In conclusion, our study showed that women can be trained to successfully self-administer the monthly injectable contraceptive Cyclofem and generally respond positively to UniJect.

Evaluation of the clinical performance of a levonorgestrel-releasing IUD, up to seven years of use, in Campinas, Brazil

The clinical performance of a levonorgestrel IUD, releasing 20 mcg/day, used by 293 women at the Family Planning Clinic of the State University of Campinas, was evaluated up to the end of the seventh year of use. No pregnancies occurred in 899 women-years of observation. The cumulative removal rate for amenorrhea or severe hypomenorrhea was 15.7 per 100 women at seven years. The expulsion rate was within ranges observed with copper IUDs in the same clinic. The continuation rate was 49.5% at three years and 23.7 at seven years. The cumulative loss to follow-up rate was 13.7% at seven years. The effectiveness, good continuation rate, and reduction of the amount of blood loss make this device appropriate to be offered to Brazilian women, as an additional contraceptive option.

Uniject® as a delivery system for the once-a-month injectable contraceptive Cyclofem® in Brazil

This study assessed the administration of Cyclofem using prefilled Uniject devices. A total of 480 injections were administered divided equally between standard syringes and Uniject. The majority of women (82%) reported that they felt anxious prior to receiving the injection with Uniject. After injection, more than 80% expressed no anxiety about the appearance of Uniject or about the technique of injection. A total of 96.3% of the participants reported slight to no pain with Uniject. In comparison to the standard syringe, 5.6% expressed having had more pain with Uniject. Ninety percent of the service providers reported that Uniject was easy to activate and inject and that it was reassuring for users to know that the syringe and needle had never been used previously. Only two service providers demonstrated difficulties in activating the device. No accidental punctures occurred during the manipulation, and incomplete emptying of the Uniject was not observed. In conclusion, Uniject is a good device for the administration of the injectable contraceptive Cyclofem. It is likely to be appropriate for the delivery of other injectable contraceptives after the necessary stability tests have been performed.

Prostate-specific antigen in vaginal fluid after exposure to known amounts of semen and after condom use: comparison of self-collected and nurse-collected samples

BACKGROUND Prostate-specific antigen (PSA) in vaginal fluid indicates exposure to semen, and was used to assess condom effectiveness, although validity and reliability have not been fully evaluated. Our objective was to compare PSA in self-collected samples with samples collected by a nurse. METHODS We conducted two studies, each with 100 women aged 18-48 years. In the first, a nurse exposed each participant to her partners semen (10, 100 and 1000 microl), and nurse and participant collected samples. In the second, each participant sampled before and after using two male condoms (MC) and two female condoms (FC); a nurse collected another sample afterwards. RESULTS PSA concentration increased with semen exposure, but was lower in nurse-collected samples. Both procedures were sensitive, almost 100% after exposure to 100-1000 microl of semen. PSA detection rates with MC and FC were 13% and 28% in self-collected samples, 8% and 9% in nurse-collected samples. Concordance between sample types was 93% with the MC (95% CI: 89%; 96%), 78% with the FC (95% CI: 72%; 84%). PSA decay between sampling times may explain higher values in self-collected samples. CONCLUSIONS PSA is a highly sensitive surrogate endpoint for condom effectiveness studies. Self-collected and nurse-collected samples are equivalent, but sample collection timing is critical.

Management of missing strings in users of intrauterine contraceptives.

BACKGROUND A common question among health care professionals is how to manage nonvisible strings in users of intrauterine contraceptives (IUCs) at repeat follow-up visits. This study assessed the position of the IUCs in women who consulted repeatedly with nonvisible IUC strings. STUDY DESIGN The medical records of the clinic were reviewed to identify new acceptors and switchers who had an IUC inserted between 1990 and 2009. All women were identified whose IUC string could not be visualized at the external os of the cervix by the health care professional at any given follow-up visit, even after attempting a standard maneuver of sweeping the strings from the cervical canal using a cervical brush or trying to visualize the strings in the cervical canal using colposcopy. Data were also retrieved on the use of ultrasonography and/or pelvic X-ray to assess IUC position, as well as data from any subsequent visits at which the IUC strings were nonvisible. RESULTS The medical charts of 14,935 patients using an IUC were reviewed, and 750 women (5.0%) presenting for the first time with missing IUC strings at any follow-up visit were identified. Ultrasound scans showed the IUC to be in situ in 735 cases (98.0%), while 9 women (1.2%) had expelled the device and, in 5 cases (0.7%), the device was found in the pelvis following uterine perforation. IUC strings were missing on a second occasion in 297 cases. The device was found to be in situ in 295 cases (99.3%) and had been expelled in 2 (0.7%). At subsequent consultations, (between 1 and 18 years after the first consultation), strings were missing in 113, 55, 19 and 5 cases. In 111 (98.2%), 54 (98.2%), 18 (94.7%) and 5 (100%) of these cases, respectively, the IUC was found to be in situ, while in the remaining cases, the device had been expelled. CONCLUSIONS Missing IUC strings are an uncommon finding, and ultrasonography confirmed that the device was in situ in the majority of these cases. For women with persistent missing IUC strings after one ultrasound scan that has verified appropriate intrauterine position, given the 2.4% likelihood that expulsion may have occurred at the time of subsequent visits, repeating the ultrasound (if available) should be considered for at least one (and possibly two) additional womens visit.

Length of the endometrial cavity as measured by uterine sounding and ultrasonography in women of different parities.

BACKGROUND In view of current controversies regarding the need for new, shorter intrauterine devices (IUDs) that would reduce expulsion rates in nulligravida, endometrial cavity length was measured in women of different parities using uterine sounding and ultrasonography. STUDY DESIGN A cross-sectional descriptive study was performed including 570 women of 17-52 years of age, 260 of whom were nulligravida and 310 parous. RESULTS The difference in mean length between measurements taken by uterine sounding and ultrasonography was 0.28 cm. Mean endometrial cavity length was 3.84+/-0.03 cm (mean+/-S.E.M.) in nulligravida and 4.25+/-0.03 cm in parous women according to uterine sounding (p<.001) and 3.70+/-0.03 cm and 3.84+/-0.03 cm, respectively, according to ultrasonography (p=.006). CONCLUSIONS By either technique, mean length of the endometrial cavity was >3.6 cm, the length of the most common IUDs, the TCu380A and the levonorgestrel-releasing intrauterine system. Therefore, the issue appears controversial for developing new, shorter IUDs, since current models fit most women, including nulligravida, albeit one third of the women of our sample showed endometrial length shorter than 3.2 cm.

Human vaginal histology in long-term users of the injectable contraceptive depot-medroxyprogesterone acetate.

OBJECTIVES Apparently, depot-medroxyprogesterone acetate (DMPA) increases a womans risk of acquiring HIV. The objective of this study was to test whether the vaginal mucosal thickness and Langerhans cell counts were significantly different in long-term DMPA users compared with women users of an intrauterine device (IUD) who had never used DMPA. STUDY DESIGN Cross-sectional study. Twenty-three DMPA users were matched with 23 nonusers controlled for age, body mass index (BMI; kg/m²), and duration of contraceptive use. Four groups of women were evaluated according to the duration of DMPA use: >1, <5; ≥5, <10; ≥10, <15 or ≥15 years. Estradiol (E₂) levels were compared between the two groups. Histologic sections of vaginal mucosal biopsies were evaluated to measure the mean epithelial thickness and S100 immunostained sections were used to count the number of Langerhans cells/mm. RESULTS Mean (±S.D.) E₂ levels were significantly lower in DMPA users (39.4±26.6 pg/mL) compared with nonusers (102.6±60.3 pg/mL) despite similar ages (42.3±7.4 and 42.4±7.4 years, respectively). Mean (±S.D.) vaginal thickness was 232.6±108.1 and 229.7±112.9 in DMPA users and nonusers, respectively. There were no differences in vaginal thickness or Langerhans cell count/mm between users and nonusers even after controlling for DMPA duration of use. CONCLUSIONS Vaginal epithelial thinning or Langerhans cell count was not different between long-term DMPA users and copper-IUD users who had never used DMPA. IMPLICATIONS No differences were found in vaginal epithelial thickness or in Langerhans cell count between long-term users of the injectable contraceptive DMPA and nonusers.

Opção pela vasectomia e relações de gênero

Realizou-se um estudo qualitativo para conhecer o processo de decisao de casais pela vasectomia, as relacoes de genero envolvidas e identificar as fontes de informacao sobre o metodo. Foram feitas entrevistas semi-estruturadas com vinte casais que solicitaram a vasectomia no Ambulatorio de Reproducao Humana do Centro de Assistencia Integral a Saude da Mulher, Universidade Estadual de Campinas. Para a analise dos dados, utilizou-se a tecnica de analise do conteudo. A maioria dos casais optou pela vasectomia como ultimo recurso anticoncepcional, apos ter utilizado outros metodos, nem sempre com sucesso. Os homens se auto-atribuiram a iniciativa de se submeterem a cirurgia dada a impossibilidade de criarem mais filhos. Pessoas significativas para eles foram as principais fontes de informacao, suscitando interesse pelo metodo e afastando os temores. As relacoes de genero desveladas oscilaram entre um modelo quase patriarcal, com o predominio dos homens nas decisoes da vida familiar, e um modelo ambiguo nas decisoes reprodutivas, em que as mulheres haviam assumido a responsabilidade da anticoncepcao ate que, diante da inevitabilidade da esterilizacao, os homens consideraram que deveriam colaborar.A qualitative study was performed to: investigate the process that leads couples to decide for vasectomy; characterize the gender relations involved in this process; and identify sources of information on vasectomy. Semi-structured interviews were conducted with 20 couples who had requested vasectomy at the outpatient clinic of the Center for Integrated Womens Health Care, State University in Campinas, São Paulo, Brazil. A structured form was used to collect social, economic, and demographic data. The content analysis technique was used for data analysis. The majority of couples opted for vasectomy as a last resort after attempting numerous other contraceptive methods, not always successfully. The emerging gender relations showed fluctuation between: (1) a more rigid, quasi-patriarchal model characterized by male predominance in the familys decision-making and (2) a more ambiguous model in relation to reproductive decisions, whereby women assumed responsibility for contraception until the situation became untenable, at which point men faced up to the unavoidable necessity of sterilization. At this point the male partners felt they should collaborate.

In vitro assessment of some sperm function following exposure to levonorgestrel in human fallopian tubes

BackgroundThe mechanism of action of levonorgestrel (LNG) as emergency contraception (EC) remains a subject of debate and its effect on sperm function has been only partially explained. The aim of this study was to assess whether LNG at a similar dose to those found in serum following oral intake for EC could affect spermatozoa when exposed to human fallopian tubes in vitro.MethodsFifteen mini-laparotomies were performed, the side on which ovulation occurred was recorded, and both tubes were removed and perfused with a suspension containing 1 × 10(6) motile spermatozoa, with or without LNG. Following 4-hour incubation, the tubes were sectioned to separate the isthmus and the ampulla. Each segment was flushed and the material was evaluated to quantify the number of motile sperm, the number of spermatozoa adhering to the oviductal epithelium and the acrosome reaction (AR) rate.ResultsThe addition of LNG did not significantly alter the number of recovered motile spermatozoa either at the isthmus or at the ampulla, nor did it have any effect on the number of recovered spermatozoa adhered to the human tubal epithelium. Furthermore, LNG did not affect the AR rate. No significant differences were found even when the side on which ovulation occurred was taken into account.ConclusionsIn a similar dose to that observed in serum following oral intake for EC, LNG had no effect on the number of motile spermatozoa recovered from the human fallopian tubes in vitro, on their adhesion to the tubal epithelium, distribution or AR rate. The possible effect of LNG as EC on sperm function remains poorly understood.