BACKGROUND-Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. METHODS-We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12. RESULTS-A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group.
(Abstracted from N Engl J Med 2020;382:1906–1915) Worldwide, 15% to 50% of women of reproductive age have bacterial vaginosis (BV) and are treated with an antibiotic agent. Within 3 months after treatment, the infection recurs in 20% to 75% of women.
In intertidal zones, tidal cycles reduce water depths and provide areas of shallow water where wading birds can forage for aquatic prey (water depths 0-50 cm). However, a bird that forages diurnally can make use of only a portion of the tidal cycle, which can limit fulfillment of energetic demands. Furthermore, daily and biweekly (spring-neap) tides may compound effects on shallow-water availability for foraging birds. However, the relative effects of daily and biweekly tidal periodicities on the foraging ecology of wading birds are seldom investigated due to a lack of appropriate tools. Therefore, we developed a tidal simulation model to provide dynamic spatiotemporal estimates of the availability of water depths that are within the upper and lower bounds of the birds' foraging water depth limits (''shallow-water availability''). We studied two wading bird species, the Little Blue Heron (Egretta caerulea), a daytime-only forager, and the Great White Heron (Ardea herodias occidentalis), which feeds both diurnally and nocturnally, to evaluate the relative effects of daily and biweekly tides on shallow-water availability and on patterns in abundance of foraging birds. Seasonal foraging surveys (n ¼ 38; 2011-2013) were conducted by boat along a 14-km transect adjacent to extensive intertidal flats in the lower Florida Keys, USA. For both species combined, biweekly tides resulted in a 0.61-to 6.09-fold change in abundance, whereas daily tides resulted in a 1.03-to 5.81-fold change in abundance. Diurnal shallow-water availability was not consistently correlated in magnitude or direction with spring-neap tidal cycles because differences in tide height between consecutive low tides were larger than changes in tidal amplitude from spring-neap tide cycles. Thus, the strong response by birds to the spring-neap tide was likely driven by mechanisms other than diurnal shallow-water availability alone.
Objective To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. Design Randomized, prospective clinical trial Patients 900 couples with unexplained infertility Interventions: Ovarian stimulation with gonadotropins, clomiphene citrate, or letrozole in conjunction with intrauterine insemination. Setting Multicenter University based clinical practices. Main Outcome Measures Demographic, laboratory, imaging, and survey characteristics. Interventions Collection of baseline demographics, blood samples, and ultrasonographic assessments. Results Demographic characteristics of women receiving clomiphene citrate, letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7± 25.7 months, with 59% primary infertility. More than 1/3 of the women were current or past smokers. The mean BMI was 27 and mean AMH level was 2.6; only 11 women (1.3%) had antral follicle counts of less than 5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. Conclusion The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, AMH levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment subgroups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and clomiphene citrate treatment.
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