Progestin-only contraceptives: effects on weight.

BACKGROUND: Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. Many POCs are long-acting, cost-effective methods of preventing pregnancy. However, concern about weight gain can deter the initiation of contraceptives and cause early discontinuation among users. OBJECTIVES: The primary objective was to evaluate the association between progestin-only contraceptive use and changes in body weight. SEARCH STRATEGY: We searched MEDLINE, CENTRAL, POPLINE, EMBASE, LILACS, ClinicalTrials.gov, and ICTRP, and contacted investigators to identify other trials. SELECTION CRITERIA: All comparative studies were eligible that examined a POC versus another method or no contraceptive. The primary outcome was mean change in body weight or body composition. DATA COLLECTION AND ANALYSIS: Two authors extracted the data. We computed the mean difference with 95% confidence interval (CI) for continuous variables and odds ratio with 95% CI for dichotomous variables. MAIN RESULTS: We did not conduct meta-analysis due to the various contraceptive methods and weight change measures. Fifteen studies examined progestin-only pills (N=1), Norplant (N=4), and depot medroxyprogesterone acetate (DMPA) (N=10). Comparison groups were similar for weight change in 11 studies. Four studies showed differences in weight or body composition change for POCs compared to no hormonal method. Adolescents using DMPA had a greater increase in body fat (%) versus a group using no hormonal method (mean difference 11.00; 95% CI 2.64 to 19.36). The DMPA group also had a greater decrease in lean body mass (%) (mean difference -4.00; 95% CI -6.93 to -1.07). In another study, weight gain (kg) was greater for the DMPA group than an IUD group (mean difference 2.28, 2.71, 3.17, respectively). The differences were notable within the normal weight and overweight subgroups. One study showed the Norplant (six-capsule) group had greater weight gain (kg) than a non-hormonal IUD group (mean difference 0.47 (95% CI 0.29 to 0.65) and a group using non-hormonal or no method (mean difference 0.74; 95% CI 0.52 to 0.96). Another study also showed a Norplant group also had greater weight gain (kg) than an IUD group (mean difference 1.10; 95% CI 0.36 to 1.84). AUTHORS' CONCLUSIONS: We found little evidence of weight gain when using POCs. Mean gain was less than 2 kg for most studies up to 12 months, and usually similar for the comparison group using another contraceptive. Appropriate counseling about typical weight gain may help reduce discontinuation of contraceptives due to perceptions of weight gain.

Theory-based interventions for contraception.

BACKGROUND: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, educational interventions addressing contraception often have no stated theoretical base. OBJECTIVES: Review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice; encourage contraceptive use; or promote adherence to, or continuation of, a contraceptive regimen. SEARCH STRATEGY: We searched computerized databases for trials that tested a theory-based intervention for improving contraceptive use (MEDLINE, POPLINE, CENTRAL, PsycINFO, EMBASE, ClinicalTrials.gov, and ICTRP). We also wrote to researchers to find other trials. SELECTION CRITERIA: Trials tested a theory-based intervention for improving contraceptive use. We excluded trials focused on high-risk groups and preventing sexually transmitted infections or HIV. Interventions addressed the use of one or more contraceptive methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy, contraceptive choice, initiating or changing contraceptive use, contraceptive regimen adherence, and contraception continuation. DATA COLLECTION AND ANALYSIS: The primary author evaluated abstracts for eligibility. Two authors extracted data from included studies. We calculated the odds ratio for dichotomous outcomes. No meta-analysis was conducted due to intervention differences. MAIN RESULTS: Fourteen RCTs met our inclusion criteria. In 2 of 10 trials with pregnancy or birth data, a theory-based group showed better results. Four of 10 trials with contraceptive use data (other than condoms) showed better outcomes in an experimental group. For condom use, a theory-based group had favorable results in three of eight trials. Social Cognitive Theory was the main theoretical basis for five trials, of which three showed positive results. Two based on other social cognition models had favorable results, as did two of four focused on motivational interviewing. Thirteen trials provided multiple sessions or contacts. Of seven effective interventions, five targeted adolescents, including four with group sessions. Three effective trials had individual sessions. Seven trials were rated as having high or moderate quality; three of those had favorable results. AUTHORS' CONCLUSIONS: Family planning researchers and practitioners could adapt the effective interventions. Reproductive health needs high-quality research on behavior change, especially for clinical and low-resource settings. More thorough use of single theories would help, as would better reporting on research design and intervention implementation.

Phase I safety and immunogenicity trial of Plasmodium vivax CS derived long synthetic peptides adjuvanted with montanide ISA 720 or montanide ISA 51.

We assessed the safety, tolerability, and immunogenicity of a mixture of three synthetic peptides derived from the Plasmodium vivax circumsporozoite protein formulated in Montanide ISA 720 or Montanide ISA 51. Forty healthy malaria-naive volunteers were allocated to five experimental groups (A-E): four groups (A-D) were immunized intramuscularly with 50 and 100 µg/dose injections of a mixture of N, R, and C peptides formulated in the two different adjuvants at 0, 2, and 4 months and one group was administered placebo. Vaccines were immunogenic, safe, well tolerated, and no serious adverse events related to the vaccine occurred. Seroconversion occurred in > 90% of the vaccines and antibodies recognized the sporozoite protein on immunofluorescent antibody test. Vaccines in Montanide ISA 51 showed a higher sporozoite protein recognition and interferon production. Results encourage further testing of the vaccine protective efficacy.

Hormonal contraceptives for contraception in overweight or obese women.

BACKGROUND: Obesity has reached epidemic proportions around the world. Metabolic changes in obesity and greater body mass may lead to reduced effectiveness of hormonal contraceptives, such as the skin patch, vaginal ring, implants, and injectables. We systematically reviewed the evidence on the effectiveness of hormonal contraceptives among overweight and obese women. OBJECTIVES: To examine the effectiveness of hormonal contraceptives in preventing unplanned pregnancies among women who are overweight or obese versus women of lower weight or body mass index (BMI). SEARCH STRATEGY: We searched MEDLINE, CENTRAL, POPLINE, EMBASE, ClinicalTrials.gov, and ICTRP. We also contacted investigators to identify other trials. SELECTION CRITERIA: All study designs were eligible. Any type of hormonal contraceptive could have been examined. The primary outcome was pregnancy. Overweight or obese women must have been identified by an analysis cutoff for weight or BMI (kg/m(2)). DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors; life-table rates were included where available. For dichotomous variables, we computed an odds ratio with 95% confidence interval. The main comparisons were between overweight or obese women and women of lower weight or BMI. MAIN RESULTS: We found 7 reports with data from 11 trials that included 39,531 women. One of three studies using BMI found a higher pregnancy risk for overweight or obese women. In the trial of two combination oral contraceptives, women with BMI >= 25 had greater pregnancy risk compared to those with BMI < 25 (OR 1.91; 95% CI 1.01 to 3.61). Among skin patch users, body weight was associated with pregnancy (reported P < 0.001) but BMI was not. Studies of a vaginal ring (never marketed) and a six-rod implant showed higher pregnancy rates for women weighing >= 70 kg versus those weighing < 70 kg (reported P values: 0.0013 and < 0.05, respectively). However, two implant studies showed no trend by body weight, and trials of an injectable had no pregnancies. AUTHORS' CONCLUSIONS: Body weight addresses overall body size, while BMI generally reflects the amount of fat. Only one of three studies using BMI found a higher pregnancy risk for overweight women. The efficacy of implants and injectable contraceptives may be unaffected by body mass. The field could use trials of contraceptive methods with groups stratified by BMI. The current evidence on effectiveness by BMI is limited. However, the contraceptive methods examined here are still among the most effective when the recommended regimen is followed.

Prevalence of rheumatic heart disease in children and young adults in Nicaragua.

Rheumatic heart disease (RHD) results in morbidity and mortality that is disproportionate among individuals in developing countries compared to those living in economically developed countries. The global burden of disease is uncertain because most previous studies to determine the prevalence of RHD in children relied on clinical screening criteria that lacked the sensitivity to detect most cases. The present study was performed to determine the prevalence of RHD in children and young adults in León, Nicaragua, an area previously thought to have a high prevalence of RHD. This was an observational study of 3,150 children aged 5 to 15 years and 489 adults aged 20 to 35 years randomly selected from urban and rural areas of León. Cardiopulmonary examinations and Doppler echocardiographic studies were performed on all subjects. Doppler echocardiographic diagnosis of RHD was based on predefined consensus criteria that were developed by a working group of the World Health Organization and the National Institutes of Health. The overall prevalence of RHD in children was 48 in 1,000 (95% confidence interval 35 in 1,000 to 60 in 1,000). The prevalence in urban children was 34 in 1,000, and in rural children it was 80 in 1,000. Using more stringent Doppler echocardiographic criteria designed to diagnose definite RHD in adults, the prevalence was 22 in 1,000 (95% confidence interval 8 in 1,000 to 37 in 1,000). In conclusion, the prevalence of RHD among children and adults in this economically disadvantaged population far exceeds previously predicted rates. The findings underscore the potential health and economic burden of acute rheumatic fever and RHD and support the need for more effective measures of prevention, which may include safe, effective, and affordable vaccines to prevent the streptococcal infections that trigger the disease.

Meeting the needs of adolescent post-abortion care patients in the Dominican Republic.

Counselling on contraception and contraceptive method provision are key components of post-abortion care (PAC). Some studies have suggested that adolescent PAC patients receive worse care than older women seeking these services. This study aimed to evaluate an intervention whose goal was to improve the counselling and contraceptive uptake of PAC patients, with special attention given to the needs of adolescent patients, in the four public hospitals in the Dominican Republic where PAC services were not being routinely offered. The counselling intervention effort included provider training and the development of adolescent-friendly information, education and communication (IEC) materials. Eighty-eight providers were interviewed at baseline and 6 months after the intervention was implemented. Six months after providers were trained, 140 adolescent PAC patients (< or = 19 years of age) and 134 older PAC patients (20-35 years) were interviewed about the contraceptive counselling messages and contraceptive methods they received before they were discharged from hospital. The adolescent and older PAC patients were matched on study hospital and time of arrival. Significant improvements were noted in provider knowledge and attitudes. No changes were noted in provider-reported PAC counselling behaviours, with close to 70% of providers reporting they routinely assess patients' fertility intentions, discuss contraception, assess STI/HIV risk and discuss post-abortion complications. Adolescent and older PAC patients reported receiving PAC counselling messages at similar rates. Forty per cent of adolescent PAC patients and 45% of older PAC patients who wanted to delay pregnancy were discharged with a contraceptive method. Adolescents were more likely to receive an injectable contraceptive method whereas older women were discharged with a variety of methods. The PAC counselling intervention increased provider knowledge and improved their attitudes and benefited both adolescent and older patients.

Bridging emergency contraceptive pill users to regular contraception: results from a randomized trial in Jamaica.

BACKGROUND: Emergency contraception research has shifted from examining the public health effects of increasing access to emergency contraceptive pills (ECPs) to bridging ECP users to a regular contraceptive method as a way of decreasing unintended pregnancies. STUDY DESIGN: In a randomized controlled trial in Jamaica, we tested a discount coupon for oral contraceptive pills (OCPs) among pharmacy-based ECP purchasers as an incentive to adopt (i.e., use for at least 2 months) this and other regular contraceptive methods. Women in the intervention and control arms were followed up at 3 and 6 months after ECP purchase to determine whether they adopted the OCP or any other contraceptive method. Condom use was recorded but was not considered a regular contraceptive due to its inconsistent use. RESULTS: There was no significant difference in the proportion of women who adopted the OCP, injectable or intrauterine device in the control group or the intervention group (p=.39), and only 14.6% of the sample (mostly OCP adopters) used one of these three methods. Condom use was high (44.0%), demonstrating that ECP users were largely a condom-using group. CONCLUSIONS: The discount coupon intervention was not successful. Although a small proportion of ECP users did bridge, the coupon did not affect the decision to adopt a regular contraceptive method. The study highlighted the need for bridging strategies to consider women's reproductive and sexual behaviors, as well as their context. However, in countries like Jamaica where HIV/AIDS is of concern and condom use is appropriately high, bridging may not be an optimal strategy.

Successful sporozoite challenge model in human volunteers with Plasmodium vivax strain derived from human donors.

Successful establishment of a Plasmodium vivax sporozoite challenge model in humans is described. Eighteen healthy adult, malaria-naïve volunteers were randomly allocated to Groups A-C and exposed to 3 +/- 1, 6 +/- 1, and 9 +/- 1 bites of Anopheles albimanus mosquitoes infected with P. vivax, respectively. Seventeen volunteers developed signs and symptoms consistent with malaria, and geometric mean prepatent periods of 11.1 days (9.3-11) for Group A; 10.8 days (9.8-11.9) for Group B; and 10.6 days (8.7-12.4) for Group C, with no statistically significant difference among groups (Kruskal-Wallis, P = 0.70). One volunteer exposed to eight mosquito bites did not develop a parasitemia. No differences in parasite density were observed and all individuals successfully recovered after anti-malarial treatment. None of the volunteers developed parasite relapses within an 18-month follow-up. In conclusion, malaria-naive volunteers can be safely and reproducibly infected with bites of 2-10 An. albimanus mosquitoes carrying P. vivax sporozoites. This challenge method is suitable for vaccine and anti-malarial drug testing.

Theory-based strategies for improving contraceptive use: a systematic review.

BACKGROUND: Theories and models help explain how behavior change occurs. We systematically reviewed randomized controlled trials that examined theory-based interventions for improving contraceptive use. STUDY DESIGN: We searched electronic databases for eligible trials. Primary outcomes included pregnancy and contraceptive use. We calculated the odds ratio for dichotomous outcomes and the mean difference for continuous data. RESULTS: Of 14 included trials, 10 showed positive results for a theory-based group: 2 of 10 studies with pregnancy or birth data, 4 of 9 addressing contraceptive use (for contraception) and 5 of 9 with condom use (to prevent HIV/sexually transmitted infections). An experimental group had favorable results for six of seven trials based on Social Cognitive Theory, two based on other social cognition models and two using motivational interviewing. Most interventions focused on adolescents and involved multiple sessions. CONCLUSIONS: Effects were not consistent across outcomes and comparisons. The field could benefit from thorough use of single theories and better reporting on intervention implementation.

Theory-based interventions for contraception.

BACKGROUND: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, educational interventions addressing contraception often have no stated theoretical base. OBJECTIVES: Review randomized controlled trials that tested a theoretical approach to inform contraceptive choice; encourage contraceptive use; or promote adherence to, or continuation of, a contraceptive regimen. SEARCH STRATEGY: We searched computerized databases for trials that tested a theory-based intervention for improving contraceptive use (MEDLINE, POPLINE, CENTRAL, PsycINFO, EMBASE, ClinicalTrials.gov, and ICTRP). We also wrote to researchers to find other trials. SELECTION CRITERIA: Trials tested a theory-based intervention for improving contraceptive use. We excluded trials focused on high-risk groups. Interventions addressed the use of one or more contraceptive methods. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy, contraceptive choice, initiating or changing contraceptive use, contraceptive regimen adherence, and contraception continuation. DATA COLLECTION AND ANALYSIS: The primary author evaluated abstracts for eligibility. Two authors extracted data from included studies. We calculated the odds ratio for dichotomous outcomes and the mean difference for continuous data. No meta-analysis was conducted due to intervention differences. MAIN RESULTS: Of 26 trials, 12 interventions addressed contraception (other than condoms), while 14 focused on condom use for preventing HIV or STIs. In 2 of 10 trials with pregnancy or birth data, a theory-based group showed better results. Four of nine trials with contraceptive use (other than condoms) showed better outcomes in an experimental group. For condom use, a theory-based group had favorable results in 14 of 20 trials, but the number was halved in a subgroup analysis. Social Cognitive Theory was the main theoretical basis for 12 trials, and 10 showed positive results. Of the other 14 trials, favorable results were shown for other social cognition models (N=2), motivational interviewing (N=5), and the AIDS Risk Reduction Model (N=2). No major patterns were detected by type of theory, intervention, or target population. AUTHORS' CONCLUSIONS: Family planning researchers and practitioners could apply the relevant theories and effective interventions from HIV and STI prevention. More thorough use of single theories would help inform the field about what works. Better reporting is needed on research design and intervention implementation.

Frequency and patterns of early recanalization after vasectomy.

BACKGROUND: Our understanding of early post-vasectomy recanalization is limited to histopathological studies. The objective of this study was to estimate the frequency and to describe semen analysis patterns of early recanalization after vasectomy. METHODS: Charts displaying serial post-vasectomy semen analyses were created using the semen analysis results from 826 and 389 men participating in a randomized trial of fascial interposition (FI) and an observational study of cautery, respectively. In the FI trial, participants were randomly allocated to vas occlusion by ligation and excision with or without FI. In the cautery study, sites used their usual cautery occlusion technique, two with and two without FI. Presumed early recanalization was based on the assessment of individual semen analysis charts by three independent reviewers. Discrepancies were resolved by consensus. RESULTS: Presumed early recanalization was characterized by a very low sperm concentration within two weeks after vasectomy followed by return to large numbers of sperm over the next few weeks. The overall proportion of men with presumed early recanalization was 13% (95% CI 12%-15%). The risk was highest with ligation and excision without FI (25%) and lowest for thermal cautery with FI (0%). The highest proportion of presumed early recanalization was observed among men classified as vasectomy failures. CONCLUSION: Early recanalization, occurring within the first weeks after vasectomy, is more common than generally recognized. Its frequency depends on the occlusion technique performed.

Safety and elicitation of humoral and cellular responses in colombian malaria-naive volunteers by a Plasmodium vivax circumsporozoite protein-derived synthetic vaccine.

Substantial experimental evidence indicates that the Plasmodium circumsporozoite (CS) protein has great potential as a vaccine candidate. We tested the safety and immunogenicity of vaccines composed of P. vivax CS-derived synthetic peptides. Sixty-nine healthy, malaria-naive volunteers were randomized to receive three injections of placebo or synthetic proteins N, R, or C (10, 30, or 100 microg/dose) in a double-blinded fashion. Vaccines were well tolerated and no serious adverse events were observed. Peptides N and R elicited humoral responses at all doses; peptide C elicicted these responses only at doses of 30 and 100 microg. The N peptide at a dose of 100 microg elicited the greatest antibody response. Antibodies to the three peptides recognized P. vivax sporozoites in an immunofluorescent antibody test. Peripheral blood mononuclear cells from most immunized volunteers also produced interferon-gamma upon peptide in vitro stimulation. These vaccines appear safe, well tolerated, and immunogenic in malaria-naive volunteers. Further optimization and development of this vaccine is being attempted to conduct phase II clinical trials.

A comparison of vas occlusion techniques: cautery more effective than ligation and excision with fascial interposition.

BACKGROUND: Vasectomy techniques have been the subject of relatively few rigorous studies. The objective of this analysis was to compare the effectiveness of two techniques for vas occlusion: intraluminal cautery versus ligation and excision with fascial interposition. More specifically, we aimed to compare early failure rates, sperm concentrations, and time to success between the two techniques. METHODS: We compared semen analysis data from men following vasectomy using two occlusion techniques. Data on intraluminal cautery came from a prospective observational study conducted at four sites. Data on ligation and excision with fascial interposition came from a multicenter randomized controlled trial that evaluated the efficacy of ligation and excision with versus without fascial interposition. The surgical techniques used in the fascial interposition study were standardized. The surgeons in the cautery study used their customary techniques, which varied among sites in terms of type of cautery, use of fascial interposition, excision of a short segment of the vas, and use of an open-ended technique. Men in both studies had semen analyses two weeks after vasectomy and then approximately every four weeks. The two outcome measures for the analyses presented here are (a) time to success, defined as severe oligozoospermia, or <100,000 sperm/mL in two consecutive semen analyses; and (b) early vasectomy failure, defined as >10 million sperm/mL at week 12 or later. RESULTS: Vasectomy with cautery was associated with a significantly more rapid progression to severe oligozoospermia and with significantly fewer early failures (1% versus 5%). CONCLUSION: The use of cautery improves vasectomy outcomes. Limitations of this comparison include (a) the variety of surgical techniques in the cautery study and differences in methods of fascial interposition between the two studies, (b) the uncertain correlation between sperm concentrations after vasectomy and the risk of pregnancy, and (c) the use of historical controls and different study sites.

Effectiveness of vasectomy using cautery.

BACKGROUND: Little evidence supports the use of any one vas occlusion method. Data from a number of studies now suggest that there are differences in effectiveness among different occlusion methods. The main objectives of this study were to estimate the effectiveness of vasectomy by cautery and to describe the trends in sperm counts after cautery vasectomy. Other objectives were to estimate time and number of ejaculations to success and to determine the predictive value of success at 12 weeks for final status at 24 weeks. METHODS: A prospective, non-comparative observational study was conducted between November 2001 and June 2002 at 4 centers in Brazil, Canada, the UK, and the US. Four hundred men who chose vasectomy were enrolled and followed for 6 months. Sites used their usual cautery vasectomy technique. Earlier and more frequent than normal semen analyses (2, 5, 8, 12, 16, 20, and 24 weeks after vasectomy) were performed. Planned outcomes included effectiveness (early failure based on semen analysis), trends in sperm counts, time and number of ejaculations to success, predictive value of success at 12 weeks for the outcome at 24 weeks, and safety evaluation. RESULTS: A total of 364 (91%) participants completed follow-up. The overall failure rate based on semen analysis was 0.8% (95% confidence interval 0.2, 2.3). By 12 weeks 96.4% of participants showed azoospermia or severe oligozoospermia (< 100,000 sperm/mL). The predictive value of a single severely oligozoospermia sample at 12 weeks for vasectomy success at the end of the study was 99.7%. One serious unrelated adverse event and no pregnancies were reported. CONCLUSION: Cautery is a very effective method for occluding the vas. Failure based on semen analysis is rare. In settings where semen analysis is not practical, using 12 weeks as a guideline for when men can rely on their vasectomy should lessen the risk of failure compared to using a guideline of 20 ejaculations after vasectomy.

Vasectomy by ligation and excision, with or without fascial interposition: a randomized controlled trial [ISRCTN77781689].

BACKGROUND: Randomized controlled trials comparing different vasectomy occlusion techniques are lacking. Thus, this multicenter randomized trial was conducted to compare the probability of the success of ligation and excision vasectomy with, versus without, fascial interposition (i.e. placing a layer of the vas sheath between two cut ends of the vas). METHODS: The trial was conducted between December 1999 and June 2002 with a single planned interim analysis. Men requesting vasectomies at eight outpatient clinics in seven countries in North America, Latin America, and Asia were included in the study. The men were randomized to receive vasectomy with versus without fascial interposition. All surgeons performed the vasectomies using the no-scalpel approach to the vas. Participants had a semen analysis two weeks after vasectomy and then every four weeks up to 34 weeks. The primary outcome measure was time to azoospermia. Additional outcome measures were time to severe oligozoospermia (<100 000 sperm/mL) and vasectomy failure based on semen analyses. RESULTS: We halted recruitment after the planned interim analysis, when 841 men had been enrolled. Fascial interposition decreased time to azoospermia (hazard ratio [HR], 1.35; P < 0.0001) and time to severe oligozoospermia (HR, 1.32; P < 0.0001) and reduced failures based on semen analysis by about half, from 12.7% (95% confidence interval [CI], 9.7 to 16.3) to 5.9% (95% CI, 3.8 to 8.6) (P < 0.0001). Older men benefited less from fascial interposition than younger men in terms of the speed of achieving azoospermia. However, the number of vasectomy failures was reduced to a similar degree in all age groups. Slightly more adverse events occurred in the fascial interposition group, but the difference was not significant. These failure rates may appear high to practitioners in countries such as the USA, but they are similar to results from other careful studies of ligation and excision techniques. CONCLUSION: Fascial interposition significantly improves vasectomy success when ligation and excision is the method of vas occlusion. A limitation of this study is that the correlation between postvasectomy sperm concentrations and risk of pregnancy is not well quantified.

A prospective study of time and number of ejaculations to azoospermia after vasectomy by ligation and excision.

PURPOSE: We obtained detailed information on the time and number of ejaculations to azoospermia after vasectomy by ligation and excision. MATERIALS AND METHODS: Men seeking vasectomy at 3 public clinics in Mexico City were invited to participate in this prospective noncomparative study. Vasectomy was performed using the no-scalpel technique. The vas was occluded using 2 silk sutures and the segment of vas between the ligatures was excised. Men were followed biweekly up to 24 weeks after vasectomy or until azoospermia was confirmed. Semen was examined at each visit for sperm concentration and motility. The main outcome measure was azoospermia in uncentrifuged semen samples. RESULTS: The life table rate for time to azoospermia was 81.5/100 men (95% CI 76.2 to 86.9) by the end of the study. Cumulative Kaplan-Meier event probability attained a maximum of 79.5/100 men (95% CI 73.7 to 85.2) at 70 ejaculations. Only 60/100 and 27.9/100 men were azoospermic by 12 weeks and 20 ejaculations, respectively. These end points are the commonly recommended waiting periods when semen analysis is unavailable. Of the 217 men 36 (16.6%) did not achieve azoospermia by 24 weeks, of whom 25 (11.5% of all participants) were considered to have vasectomy failure. CONCLUSIONS: Our results suggest that it is not possible to develop guidelines for clearance based only on the time or number of ejaculations when ligation and excision are performed. In addition, of the methods for vas occlusion during vasectomy ligation and excision may not provide the best success rates.

Use of a levonorgestrel-releasing intrauterine system to treat bleeding related to uterine leiomyomas.

OBJECTIVE: This study was designed to evaluate the potential usefulness of the levonorgestrel-releasing intrauterine system (LNG IUS) in treating women with uterine leiomyomas. DESIGN: Prospective before-and-after study. SETTING: Family planning unit in an academic research institute. PATIENT(S): Sixty-seven women with uterine leiomyomas who chose the LNG IUS as their method of contraception. INTERVENTION(S): Clinical and ultrasound examinations were performed prior to and 3, 6, and 12 months after the LNG IUS insertion. MAIN OUTCOME MEASURE(S): Menstrual blood loss assessed with pictorial blood loss assessment charts, ferritin and hemoglobin concentrations, and uterine and leiomyoma volume. RESULT(S): Use of the LNG IUS was associated with a marked reduction in menstrual blood loss. After 12 months of use, the mean pictorial blood loss assessment chart score declined from 97 to 16 (P<.001). Hemoglobin and ferritin levels increased significantly over 1 year of use. Eighteen of 19 women (95%) who were anemic at the beginning of the study were no longer anemic at 12 months, as judged by hemoglobin levels. No pregnancies occurred during the study. CONCLUSION(S): The LNG IUS was associated with a profound reduction in menstrual blood loss. For women with leiomyomas of this size, the LNG IUS provides effective medical treatment of bleeding.

Termination of a randomized controlled trial of two vasectomy techniques.

Family Health International (FHI) and EngenderHealth conducted a multicenter, randomized controlled trial to evaluate a fascial interposition (FI) component of a vas occlusion procedure for male sterilization. A data monitoring committee (DMC) was established to provide independent review of the interim report. The DMC met to review the interim report after enrollment of 552 men. As planned, an estimate of the hazard ratio (HR) for successful vasectomy for the FI group versus the no-FI group controlling for age of the participant and level of experience of the surgeon was obtained for the interim report using Cox's proportional hazards regression. The main analysis comparing time to vasectomy success, defined as two consecutive azoospermic semen samples, was highly significant and met the prespecified level for stopping enrollment (HR=1.54, p<0.01). However, a troublesome age by vasectomy technique interaction became apparent in the analysis. FI was clearly beneficial for younger males. However, the trend for older men was not as clear. The DMC recommended continuing the trial to better study this interaction and obtain more data to clarify the effect of FI for older men. After consulting further with the DMC, the study statisticians presented the interim report to senior management at FHI. A meeting between FHI senior management and the DMC followed. After much deliberation, trial enrollment was terminated. Follow-up of participants already enrolled in the study continued as planned. This paper presents the issues involved in the decision to terminate the study.

Psychosocial aspects of Costa Rican adolescents' eating and physical activity patterns.

PURPOSE: To determine the importance of some psychosocial aspects on the eating and physical activity patterns of Costa Rican adolescents. METHODS: A total of 1200 adolescents were included in the study. Data were collected using a self-administered instrument containing the following elements: questions to elicit demographic information and five sections with several items (stated as positive or negative behaviors) to study the influence of peers, parents, social environment, body image, and self-efficacy on five target behaviors, intake of foods rich in saturated fats, calcium, and iron, along with consumption of fruits and vegetables and physical activity practices. Data were analyzed using a factor analysis with main component extraction and varimax rotation, along with multiple regression analyses. RESULTS: Social environment and peer influence were the major factors that predict behaviors associated with the intake of foods rich in saturated fat. Meanwhile, parental and social environment influences were the main factors in explaining the fruit and vegetable intake-related behaviors. Self-efficacy was a significant predictor of behaviors associated with physical activity. Body image influence was an important variable associated with all the behaviors analyzed. Multiple regression analyses suggest that the fathers' educational level, the adolescents' age, being female, and living in a rural area may have positive influence on the behaviors studied; however, the overall R(2) for all regression models was quite small (<.03). CONCLUSIONS: Most of the variability in adolescents' food intake and physical activity-related behaviors remained unexplained by the demographic variables included in the study. Nevertheless, the results suggest that promotion of health programs built on the influence of social environment, peers and family members, and self-efficacy may have a positive impact on the adolescents' food and physical activity patterns. However, the clear definition of which psychosocial aspect(s) strongly influence the behavior to be modified, is essential for designing an intervention that is properly directed at the correct target.