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The objective of this study was to evaluate the perceived stress index, quality of life, and hypothalamus-pituitary-adrenal axis activity in women with endometriosis and chronic pelvic pain. For the study, 93 women with endometriosis and 82 healthy women volunteered. The visual analogue scale (VAS) (0=no pain; 10=severe pain) was used to determine pain intensity; the perceived stress questionnaire (PSQ) defined stress index, and the health-related quality-of-life (HRQOL)-SF-36 questionnaire was used to evaluate quality of life. Salivary cortisol was measured at 0800, 1600, and 2000 h and the awakening cortisol response was assessed to evaluate the hypothalamus-pituitary-adrenal axis activity. The results show that women with endometriosis and chronic pelvic pain of moderate intensity (4.1+/-0.58, mean+/-SEM) have higher levels of perceived stress (0.55+/-0.01 versus 0.42+/-0.01, p<0.05), a poorer quality of life expressed as lower scores for all items of the inventory and hypocortisolism. Lower levels of salivary cortisol were observed in all three samples collected, as well as in the awakening cortisol response, for women with endometriosis (0.19+/-0.09 microg/dl) when compared with controls (0.78+/-0.08 microg/dl, p<0.05 l), and it was independent of pain intensity and Mental health (MH) scores in SF-36. We concluded that women with endometriosis and chronic pelvic pain show low concentrations of salivary cortisol and a high level of perceived stress, associated with a poor quality of life. Whether the hypocortisolism was an adaptive response to the aversive symptoms of the disorder or a feature related to the etiology of endometriosis remains to be elucidated.

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BACKGROUND: Women with endometriosis may have higher rates of autoimmune disorders, including hypothyroidism. The objective of this study was to compare the prevalence of thyroid dysfunction and autoimmune thyroid disease (AITD) between women with endometriosis and a control group. METHODS: This was a cross-sectional study carried out in 148 women with surgically confirmed endometriosis and 158 controls. The mean age of the study group was 34.6 (7.1 SD) years (range 21-42) and 32.1 (7.7 SD) years (range 18-44) for controls. Serum levels of thyroid-stimulating hormone, free thyroxine and the anti-thyroperoxidase and anti-thyroglobulin antibodies were evaluated. RESULTS: Thyroid disorders were identified in 20.9% of the endometriosis group and 26.5% of the control group (P = 0.25). The overall frequency of thyroid dysfunction was 12.2% and 10.8% for the endometriosis and control groups, and the frequency of positive thyroid antibodies, 14.9% and 22.2%, respectively (P = 0.20). Endometriosis stage and infertility history were not associated with thyroid dysfunction and AITD in the study group. CONCLUSIONS: The prevalence of thyroid dysfunction and AITD was similar in the two study groups. Screening for thyroid disturbances in women with endometriosis is not indicated.

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OBJECTIVES: To investigate whether there is an association between vascular endothelial growth factor (VEGF) levels in serum and peritoneal fluid, and the presence of pelvic endometriosis and its clinical symptoms. METHODS: Blood and peritoneal fluid sample levels of VEGF were measured in 46 women undergoing laparoscopy: 32 with suspected endometriosis and 14 with confirmed endometriosis. Data were analyzed according to phase of the menstrual cycle, symptoms, disease stage, and disease site. RESULTS: There were no significant associations between serum and peritoneal fluid levels of VEGF and the presence of endometriosis, even when controlling for the menstrual phase. However, among the women with confirmed endometriosis, there was a significant increase (P=0.002) in the mean peritoneal VEGF level in those in the late secretory phase compared with those in the proliferative and early secretory phases. CONCLUSIONS: Measuring VEGF levels in symptomatic patients is not helpful to differentiate those with endometriosis from those with a different condition. However, in the late secretory and menstrual phases, mean VEGF levels were higher in women with confirmed endometriosis than in those suspected of having the disease.

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Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, and genital warts. We report data for the longest efficacy evaluation to date of a prophylactic HPV vaccine. In total, 552 women (16-23 years) were enrolled in a randomised, placebo-controlled study of a quadrivalent HPV 6/11/16/18 L1 virus-like-particle vaccine with vaccination at months 0, 2, and 6. At regular intervals through 3 years, subjects underwent gynaecologic examination, cervicovaginal sampling for HPV DNA, serum anti-HPV testing, and Pap testing, with follow-up biopsy as indicated. A subset of 241 subjects underwent two further years of follow-up. At 5 years post enrollment, the combined incidence of HPV 6/11/16/18-related persistent infection or disease was reduced in vaccine-recipients by 96% (two cases vaccine versus 46 placebo). There were no cases of HPV 6/11/16/18-related precancerous cervical dysplasia or genital warts in vaccine recipients, and six cases in placebo recipients (efficacy = 100%; 95% CI:12-100%). Through 5 years, vaccine-induced anti-HPV geometric mean titres remained at or above those following natural infection. In conclusion, a prophylactic quadrivalent HPV vaccine was effective through 5 years for prevention of persistent infection and disease caused by HPV 6/11/16/18. This duration supports vaccination of adolescents and young adults, which is expected to greatly reduce the burden of cervical and genital cancers, precancerous dysplasia, and genital warts.

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BACKGROUND: The study aim was to assess the time elapsed between onset of symptoms and diagnosis of endometriosis, and to identify the factors associated with diagnostic delay in a group of Brazilian women. METHODS: In this retrospective cohort study, 200 women with surgically confirmed endometriosis were interviewed at an endometriosis outpatient clinic. RESULTS: The median (interquartile range) time elapsed from onset of symptoms until diagnosis of endometriosis was 7.0 (range 3.5-12.1) years. The younger the women at onset of symptoms, the longer the period for diagnosis to be made: the median delay was 12.1 (range 8.0-17.2) years in women aged < or =19 years, and 3.3 (range 2.0-5.5) years in women aged > or =30 years. The median time period between onset of symptoms and diagnosis was 4.0 (2.0-6.0) years for women whose main complaint was infertility, but 7.4 (3.6-13.0) years for those with pelvic pain. CONCLUSIONS: The delay in diagnosis of endometriosis was considered to be long, and especially so for young women with pelvic pain. More information relating to endometriosis should be offered to general physicians and gynaecologists in order to reduce the time taken to diagnose this condition.

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The objective of this study was to evaluate retrospectively the weight variation in long-term users of depot medroxyprogesterone acetate (DMPA) compared to users of the TCu380A intrauterine device (IUD). A cohort of 206 healthy women allocated in two groups of 103 women according to the contraceptive method used was evaluated through 5 years. Each user of DMPA was paired with an IUD user by age (+/- 1 year) and weight (+/- 1 kg) at the beginning of the study. Weight was evaluated yearly during 5 years. The mean age at the beginning of the study was 33.1 years in both groups, and the mean weight was 59.4 kg in the IUD users and 60.4 kg in the DMPA group. Both cohorts of women presented significant weight increase at the end of the 5 years of observation (p < 0.001). However, DMPA users presented higher weight increase when compared to IUD users from the second through the fifth year of observation. The DMPA users increased weight by 4.3 kg during the 5 years, and IUD users increased 1.8 kg. In conclusion, DMPA users had a significantly higher weight increase when compared to IUD users. In addition, this cohort of women increased weight throughout the 5 years with the use of DMPA or IUD.

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OBJECTIVE: To compare the bone mineral density of users of combined oral contraceptives (OC) or depot medroxyprogesterone acetate (depot-MPA) with women who have never used a hormonal contraceptive method. DESIGN: Cross-sectional study. SETTING: Academic tertiary-care hospital. PATIENT(S): A total of 189 women, aged 30 to 34 years old, were allocated to three groups: 63 who had used OC for at least 2 years; 63 who had used depot-MPA for at least 2 years; and 63 control women who had never used hormonal contraceptives. INTERVENTION(S): Each woman's bone mineral density (BMD) was evaluated at the distal and ultradistal section of the radius of the nondominant forearm by the use of single x-ray absorptiometry. MAIN OUTCOME MEASURE(S): We obtained BMD measurements for each participant. RESULT(S): Independent of the period of use and the section of the forearm studied, we found no difference in BMD for OC or depot-MPA users when compared to women who had never used hormonal contraceptive methods. In addition, BMD was similar between OC users and depot-MPA users. The multiple linear regression analysis showed that the variables associated with BMD were weight, number of pregnancies, and the woman's occupation. CONCLUSION(S): Women aged 30 to 34 years who have used OC or depot-MPA have similar BMD as control women. These findings suggest that the use of OC or depot-MPA does not affect the BMD of women in this age group.

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OBJECTIVE: To assess whether women who were administered the first injection of DMPA+E(2)C on day 7 of their menstrual cycle (delayed injection) exhibit the same degree of ovarian suppression as women who receive it on day 5 of their menstrual cycle. DESIGN: Multicenter, randomized controlled trial. SETTING: Reproductive health clinics. PATIENT(S): Women aged between 18 and 38 years (inclusive) willing to use DMPA+E(2)C as their method of contraception. INTERVENTION(S): Participants received a DMPA+E(2)C injection on day 5 (control group, n = 41) or day 7 (delayed-injection group, n = 117) of their menstrual cycle. MAIN OUTCOME MEASURE(S): Ovarian activity and follicular development determined by serial serum progesterone levels and vaginal ultrasound. RESULT(S): Participants who received DMPA+E(2)C on day 5 of their menstrual cycle (control group) exhibited no more than limited follicular growth (no follicle >16 mm). Of those women who received DMPA+E(2)C on day 7 of their menstrual cycle (delayed-injection group), 21 (18%) showed some follicular growth, of whom 4 (3%) ovulated. CONCLUSION(S): The first injection of DMPA+E(2)C given on day 7 of a menstrual cycle does not provide the same inhibition of ovarian activity as that observed when it is administered on day 5 of the menstrual cycle.

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The objectives of this study were to assess whether women who were administered the first injection of the once-a-month contraceptive containing estradiol cypionate and 25 mg depot-medroxyprogesterone acetate (MPA+E(2)C) on Day 7 of their menstrual cycle (delayed injection) exhibit the same degree of cervical mucus changes as women who receive it on Day 5 of their menstrual cycle. This was a multicenter, randomized, controlled clinical trial. A total of 158 women, aged between 18 and 38 years (inclusive), who, were willing to use MPA+E(2)C as their contraceptive method participated in the trial. Participants received a MPA+E(2)C injection on Day 5 (control group, n = 41) or Day 7 (delayed-injection group, n = 117) of their menstrual cycle. Participants who received MPA+E(2)C on Day 5 of their menstrual cycle (control group) exhibited fair or poor mucus quality and poor sperm penetration. Of those women who received MPA+E(2)C on Day 7 of their menstrual cycle (delayed-injection group), 3 (3%) showed good mucus or good sperm penetration at some time point during follow-up. It is possible to conclude that the first injection of MPA+E(2)C given on Day 7 of a menstrual cycle does not provide the same degree of inhibition of mucus quality and sperm penetration as that observed if it is administered on Day 5. However, the theoretical risk of pregnancy after receiving MPA+E(2)C on Day 7 would be expected to be low.

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The objectives of this study were to evaluate the acceptability of the LNG-IUS Mirena(R), when offered as an additional option in a free choice context, and to evaluate the possibility of using this method in women with increased bleeding wanting an IUD and in copper IUD users requesting removal of the device for bleeding problems. A total of 256 women chose Mirena and were accepted into the study during the enrollment period. This represents 23.3% of all new acceptors of contraceptive methods in the clinic during the same period. Discontinuations were fairly evenly distributed among expulsion, bleeding changes, pain, and personal reasons. Bleeding changes were decreased bleeding, oligomenorrhea or amenorrhea. Comparing the performance in the group of women who chose the LNG-IUS as a first option with those having heavy bleeding, the only difference found was a higher expulsion rate in the group with bleeding problems. No pregnancies occurred and continuation rate was slightly over 75% in the total sample and in both groups. The characteristics of the LNG-IUS (Mirena) allow predicting that this method can effectively contribute to the increase in contraceptive options when introduced to family planning programs in Brazil.

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The objective of this study was to observe the position dynamics of the T-shaped intrauterine device (IUD) in the uterine cavity, from insertion to 90 days of use. IUD position was evaluated in 214 women by vaginal ultrasound, measuring the IUD-endometrium, IUD-myometrium, and IUD-fundus distances. The 90th percentile of the IUD-endometrium distance was 5, 6, and 8 mm at time of insertion, 30 and 90 days of use; 7, 9, and 10 mm for IUD-myometrium distance; and 23, 24, and 27 mm for IUD-fundus distance, respectively. Seventeen IUDs were classified as misplaced at insertion by using the 90th percentile of the IUD-myometrium distance as standard. Of these, only 6 remained misplaced after 90 days of use. On the other hand, 21 IUDs were beyond the 90th percentile at the 90-day observation, only 6 of which were considered misplaced at insertion. We conclude that the T-shaped IUD accommodates its position in the uterine cavity during the first 3 months following insertion, and that ultrasound evaluation of its position is not a good predictor of future evaluation.

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OBJECTIVE: To determine the influence of depot medroxyprogesterone acetate (MPA) on bone mineral density when used as a contraceptive method. DESIGN: Cross-sectional study. SETTING: Academic tertiary-care hospital. PATIENT(S): Fifty premenopausal women who had used depot MPA as a contraceptive method for > or =1 year and 50 women who had never used hormonal contraceptive methods. INTERVENTION(S): Bone mineral density was evaluated at the midshaft and at the distal radius of the nondominant forearm using single x-ray absorptiometry. MAIN OUTCOME MEASURE(S): Bone mineral density. RESULT(S): Bone mineral density at the midshaft of the forearm was lower in depot MPA users than in women who had never used hormonal contraceptive methods, but the difference was not statistically significant. At the distal portion, bone mineral density was significantly lower in the study group. The duration of depot MPA use was not related to bone mineral density. CONCLUSION(S): Women > or =35 years of age presented with a lower bone mineral density only at the distal portion of the forearm after the use of depot MPA for > or =1 year. However, this decrease was not related to the duration of depot MPA use. It is not possible to conclude that women who use depot MPA are at risk of osteoporosis.

PIP: The impact of depot medroxyprogesterone acetate use on bone mineral density was assessed in a cross-sectional study of 100 women recruited from a teaching hospital in Campinas, Brazil, during 1996-98. Bone mineral density, as evaluated at the midshaft and distal radius of the nondominant forearm by single x-ray absorptiometry, was compared in 50 women 35-45 years of age who had been using Depo-Provera for contraception for 1 year or more (mean duration, 46.4 +or- 38.6 months) but had never used any other hormonal method and 50 age- and weight-matched women who had never used any form of hormonal contraception. Although mean bone mineral density at the midshaft of the forearm was lower in Depo-Provera users than nonusers of hormonal contraception (0.459 +or- 0.042 vs. 0.474 +or- 0.049 g/sq. cm), the difference was not statistically significant. At the distal portion, bone mineral density was significantly lower in Depo-Provera users than nonusers of hormonal methods (0.362 +or- 0.040 vs. 0.392 +or- 0.049 g/sq. cm, p 0.001). The duration of Depo-Provera use was not related to bone mineral density, even when women had used the method for more than 5 years. Multiple regression analysis indicated that 4 pregnancies, White race, and Depo-Provera use were significantly associated with lower bone mineral density at the midshaft section of the forearm; at the distal section of the forearm, these variables were Depo-Provera use, more than 4 pregnancies, White race, older age at menarche, and habitual coffee drinking. These findings do not provide sufficient evidence to conclude that Depo-Provera users are at increased risk of osteoporosis.

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This study evaluated endometrial histology in women using the once-a-month injectable contraceptive Cyclofem for one year or more. The study received IRB approval. Seventeen Cyclofem users accepted to be submitted to an endometrial biopsy. All the samples were collected with an endometrial suction curette (Z-Sampler, ZSI Gynecological Product, Chasworth, CA, USA) in an outpatient clinic, 27-33 days after the last injection. The material was fixed immediately in Bouin solution prior to wax embedding and screened as a routine histological examination by a senior pathologist. The pathologist did not know the bleeding status of each woman or the number of injections each woman had received before the biopsy. All women recorded bleeding and spotting for the last 60 days prior to the biopsy. The mean age of volunteers was 25.9 years (range 21-32) and the mean number of injections received was 24.8 (range 14-47). The results were: 4 out of 17 biopsies were found to be inadequate for diagnosis because they consisted of only blood and mucus. Two of these women were bleeding regularly and the other 2 had amenorrhea. Eight endometrial samples presented a proliferative pattern and, in this group, 3 women had amenorrhea and 5 were bleeding regularly. The other 5 biopsies were reported as secretory endometrium, and 4 of them showed pseudodecidual reaction compatible with the administration of progestin. All of these women were bleeding regularly. The results of the biopsies were not related to the number of injections received nor to the age of the women. In conclusion, long-term administration of the injectable contraceptive Cyclofem did not produce adverse alterations in the endometrium as hyperplasia.

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A modification of the TCu380A IUD to create the model TCu380S was introduced many years ago. The TCu380S utilizes copper sleeves that are flush in the plastic and are set at both ends of the horizontal arm. The objective of this study is to compare the clinical performance of the TCu380A and the TCu380S IUDs, especially regarding contraceptive performance and expulsion, in a cohort of women who had one of these two devices inserted at random. This paper presents the results up to 5 years of use. A total of 1568 women were enrolled: 806 women received a TCu380A and 762 women received a TCu380S IUD. The performance was evaluated by life-table analysis and significance between rates was tested by the method of log-rank. The cumulative pregnancy rate was low in users of both models of IUD but lower in users of the TCu380S model through the 5 years of use, without statistical significance. Expulsion was significantly higher in users of the TCu380S model during the five years of use. The other reasons for discontinuation were similar for both devices and did not show statistical significance. The continuation rate was significantly lower in users of the TCu380S model in the first and second years of use. Both devices presented a very low pregnancy rate and TCu380S presented a lower pregnancy rate than the TCu380A, although without statistical significance.

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OBJECTIVE: To determine the timing of onset of contraceptive effectiveness after the first injection of 150 mg of depot medroxyprogesterone acetate (DMPA) administered between days 8 and 13 of the menstrual cycle. DESIGN: Descriptive, prospective study. SETTING: A tertiary university referral center. PATIENT(S): Thirty healthy women between 18 and 40 years of age. INTERVENTION: Volunteers were injected with DMPA between days 8 and 13 (5 women on each day) of the menstrual cycle. MAIN OUTCOME MEASURE(S): Ovarian function determined by serum levels of E2 and progesterone and follicular development evaluated by vaginal ultrasound. RESULT(S): In nine (30%) of 30 women studied, DMPA did not prevent ovulation. All ovulations occurred in women receiving DMPA between days 10 and 13 of the cycle. No woman who received injections on day 8 or 9 ovulated. Ovulation suppression was more effective in women with low ovarian activity. All ovulation occurred within 3 days after the injection. CONCLUSION: A back-up contraceptive method, used after the 7th day of the menstrual cycle, is recommended for up to 7 days after the first injection of DMPA.

PIP: To ensure ovulation does not occur, it is recommended that Depo-Provera injections be administered within the first 7 days of the menstrual cycle. In some settings, this requirement acts as a barrier to women's free access to injectable contraception. Thus, the present study investigated the timing of onset of contraceptive effectiveness when the first injection of depot medroxyprogesterone acetate is administered between days 8-13 of the menstrual cycle. 30 women 18-40 years of age attending a university referral center in Campinas, Brazil, in 1995-96, were enrolled. Ovulation, detected through serum progesterone and estradiol assays and confirmed by follicle rupture at vaginal ultrasound, occurred in 9 cases (30%). No ovulations occurred when injection was administered on day 8 (n = 5) or day 9 (n = 5) of the menstrual cycle; only 1 of the 5 women treated on day 10 ovulated. On the other hand, 4 of the 10 women treated on days 11 and 12 and 4 of the 5 injected on day 13 showed evidence of ovulation. All ovulation occurred within 3 days after injection. Ovulation occurred only among women who had serum estradiol levels of 100 pg/ml and above and a leading follicle diameter greater than 13 mm at the time of injection. Ovulation suppression was more effective in women with low ovarian activity. A back-up contraceptive method used for 4 days after Depo-Provera injection should provide sufficient protection when the method is administered after day 7 of the menstrual cycle. However, given the uncertainty of the assumption of short viability of the human oocyte, it is safer to recommend 1 week's use of a back-up method or abstinence.

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Ultrasound has been used to detect and evaluate intrauterine device (IUD) position for some years. Different definitions of the IUD in the uterine cavity have been discussed trying to relate them to bleeding and pain complaints. Most of these definitions do not take into account the uterine wall or endometrial thickness. This is a secondary analysis of a previous cross-sectional study, in which 481 IUD users had their T-shaped IUD evaluated by transvaginal sonography. The correlation between the endometrium thickness and the IUD-myometral distance was studied, defined by the linear measurement between the upper end of the IUD and the myometrium/endometrium interface. These two measurements were highly correlated over the entire sample range (r = 0.29) and an even stronger correlation existed (r = 0.66) when only cases below the 90 percentile of the IUD-endometrial distance distribution were considered. These results suggest that the IUD position in the uterine cavity is influenced by the growth and thinning of the endometrium, and that this information should be considered when evaluating the IUD position by sonography.

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OBJECTIVE: To evaluate the changes in cervical mucus within the first hours or days after depot medroxyprogesterone acetate (MPA) injection so as to estimate the time at which cervical mucus becomes hostile enough to prevent pregnancy. DESIGN: Multicenter, clinical descriptive study. SETTING: Family planning clinic. PATIENT(S): Thirty women who were between days 8 and 13 of their menstrual cycle and who had requested Depo-Provera were enrolled in the study. INTERVENTION(S): Cervical mucus and blood samples were obtained; transvaginal ultrasonography was performed. MAIN OUTCOME MEASURE(S): Cervical mucus scores, sperm penetration distances, ovarian follicular size, and serum levels of progesterone and estradiol. RESULT(S): From 6 to 24 hours after injection, there was a sharp decline in the cervical mucus score for most of the subjects. All subjects exhibited poor mucus on day 3 after injection, and by day 7, all subjects had zero scores, with the exception of two outliers on each day. Sperm penetration, as measured by the vanguard sperm distance, was already poor (< 1 cm) in 7 of the 30 subjects at the time of injection and was reduced progressively up to 24 hours after injection, when only four subjects had a sperm penetration of > 1 cm. A rapid decline in the estimated number of sperm was observed at 12 hours and more so at 24 hours in the majority of subjects. CONCLUSION(S): The data presented in this report confirmed that depot MPA causes profound changes in cervical mucus after injection. Although very little change was seen at 6 hours, alterations were observed subsequently, with 90% of the subjects showing a poor cervical mucus score 24 hours after administration of the progestin. No reliable clinical marker is available to identify in which women depot MPA might exert its effect on cervical mucus within 3 days. Thus, we believe that at present, women should be informed of this uncertainty and should use a backup method of contraception for 7 days when the first injection of depot MPA is provided after the seventh day of the menstrual cycle.

PIP: More accurate knowledge of the time of onset of cervical mucus changes after Depo-Provera injection would enable family planning providers to counsel new acceptors to use a backup method only for the amount of time it is really needed. To obtain such data, 30 women from a family planning clinic in Campinas, Brazil, who requested Depo-Provera in 1995-96 were recruited. At baseline, 11 women had a poor cervical mucus score (0-4), 12 had a fair score (3-8), and 7 scored in the good range (9-12). Between 6 and 24 hours after injection, a sharp decline occurred in the cervical mucus score in all but 3 patients (each of whom had a "good" score at baseline). On day 3, 29 women had "poor" mucus and the remaining woman had a cervical mucus score in the fair range. By day 7, 29 women had zero mucus scores; the score in the last woman was 1. 24 hours after injection, sperm penetration (measured by vanguard sperm distance) had decreased to under 1 cm in all but 4 women. At day 3, 1 of the 2 women with good penetration at 24 hours maintained a vanguard sperm distance of 2.5 cm and an estimated sperm count of 15,363. By day 7, sperm penetration was zero in all but 1 woman (0.5 cm). These findings confirm that depot medroxyprogesterone acetate causes profound changes in cervical mucus after injection. The lack of a more complete hostility to sperm penetration at day 3 was unexpected, however. Given the nonavailability of a reliable clinical marker to verify a contraceptive effect at 3 days, it seems prudent to advise new Depo-Provera acceptors to use a backup method for the first 7 days.

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The objectives of this study were to define the "normal" position of the T-shaped intrauterine device (IUD) in the endometrial cavity, using transvaginal ultrasound, and to compare the IUD's position in women with and without complaints of bleeding and/or pain. Vaginal ultrasound was carried out in women who had used a T-Cu 200 or T-Cu 380 for at least 6 months. Of these women, 236 registered bleeding complaints and/or pain and 245 had no complaints. The distances, IUD-endometrium, IUD-myometrium, and IUD-fundus, were measured in each woman. Our results showed that women with and without complaints presented no significant differences in age, parity, type of IUD, duration of use, previous contraceptive method used, hysterometry, uterine position, or period of the cycle in which the ultrasound was performed. The values of the three distances in users without complaints were widely dispersed. The 90th percentile of the IUD-endometrium, IUD-myometrium, and IUD-fundus distances were 7, 11, and 27 mm, respectively. The curve of the values for the three distances among women with complaints was similar to that of the subjects without complaints. Using the generally accepted measurement of 20 or 25 mm as the limits of normality of the distance IUD-fundus, and the 90th percentile of the distance IUD-endometrium as the gold standard, 77% and 43% of the women were false positives for "incorrect IUD position." Similar results were obtained when the 90th percentile of the distance IUD-myometrium was used as a gold standard. We concluded that the 90th percentiles of the distance IUD-endometrium, IUD-myometrium, and IUD-fundus were 7, 11 and 27 mm, respectively, among users without complaints. The ultrasonographic diagnosis of the IUD position was unable to discriminate between women who did or did not have complaints of bleeding and/or pain. If ultrasound were to be performed in T-shaped IUD users, the IUD-myometrium distance is likely to be the most reliable measurement.

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The objective of this study was to evaluate the return of fertility in women who used Cyclofem as a contraceptive method during the introductory studies conducted in Brazil, Chile, Colombia, and Peru. From these four cohorts, 101 women were eligible for the study. Thirty-one were not included in the study either because they refused to be interviewed, had initiated another contraceptive method the month after discontinuation, or were unable to be contacted. A total of 70 women were included in the study. Our results showed that the return to fertility rate after the discontinuation of Cyclofem was 1.4 per 100 women at the end of the first month and reached 82.9 at one year. More than 50% were pregnant at 6 months. Fifty-one (94.4%) pregnancies ended in a live birth, two were spontaneous first trimester abortions, and one was a hydatidiform mole. Return of fertility was not related to the woman's age at the time of discontinuation, her weight, or the number of Cyclofem injections. In conclusion, fertility is restored by 1 month following Cyclofem discontinuation. Users and potential users should be counseled regarding the rapid return of fertility after discontinuing this method of contraception.

PIP: Cyclofem, a monthly injectable contraceptive containing 5 mg estradiol cypionate and 25 mg medroxyprogesterone acetate, has been registered in several Latin American countries; however, the return to fertility after method discontinuation has not been investigated. To address this issue, 70 women were followed who had participated in introductory studies in Brazil, Chile, Colombia, and Peru during 1992-94 and who then discontinued injectable use to achieve pregnancy. The mean number of Cyclofem injections was 7.1 (range, 1-19). The fertility rate was 1.4 at the end of the first month after Cyclofem discontinuation, 52.9 after 6 months, and 82.9 at 12 months. 55 pregnancies (94.8%) ended in live-term births, with no congenital malformations; there were 2 spontaneous abortions in the first trimester. The number of months required to become pregnant was not significantly associated with maternal age, body weight, number of injections, or country site. The return to fertility for this method is comparable to that following discontinuation of copper IUDs, barrier methods, and oral contraceptives. Since information on return to fertility is essential to informed choice, these findings should be incorporated into educational and counseling materials for providers and potential acceptors of this new contraceptive method.

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