A randomized single-blind non-inferiority trial of delayed start with drospirenone-only and ethinyl estradiol-gestodene pills for ovulation inhibition.

We compared the efficacy of 4 mg drospirenone (DRSP) progestin-only pills (POPs) versus combined oral contraceptive pills (COCs) containing 0.02 mg of ethinyl estradiol (EE) and 0.075 mg of gestodene (GS) in ovulation inhibition and inducing unfavorable cervical mucus changes using a delayed-starting approach. This randomized controlled trial involved 36 participants aged 18-45 years. The major outcomes included ovulation inhibition assessed using the Hoogland and Skouby score, and cervical mucus permeability, assessed using the modified World Health Organization score. The results demonstrated ovulation inhibition rates of 77.8% for the EE/GS group and 88.9% for the DRSP group. The risk ratio and absolute risk reduction were 0.50 (95% confidence interval [CI]: 0.10, 2.40) and - 0.11 (95% CI: - 0.35, 0.13), respectively, satisfying the 20% non-inferiority margin threshold. The median time to achieve unfavorable cervical mucus changes was comparable between the DRSP (3 days, interquartile range [IQR]: 6 days) and EE/GS (3.5 days, IQR: 4 days) groups. However, the DRSP group had a higher incidence of unscheduled vaginal bleeding (55.56% vs. 11.11%; p = 0.005). DRSP-only pills, initiated on days 7-9 of the menstrual cycle, were non-inferior to EE/GS pills in ovulation inhibition. However, they exhibited delayed unfavorable cervical mucus changes compared to the standard two-day backup recommendation.Clinical trial registration: Thai Clinical Trials Registry (TCTR20220819001) https://www.thaiclinicaltrials.org/show/TCTR20220819001 .

Influence of hydrogel encapsulation during cryopreservation of ovarian tissues and impact of post-thawing in vitro culture systems in a research animal model.

OBJECTIVE: Using domestic cats as a biomedical research model for fertility preservation, the present study aimed to characterize the influences of ovarian tissue encapsulation in biodegradable hydrogel matrix (fibrinogen/thrombin) on resilience to cryopreservation, and static versus non-static culture systems following ovarian tissue encapsulation and cryopreservation on follicle quality. METHODS: In experiment I, ovarian tissues (n=21 animals; 567 ovarian fragments) were assigned to controls or hydrogel encapsulation with 5 or 10 mg/mL fibrinogen (5 or 10 FG). Following cryopreservation (slow freezing or vitrification), follicle viability, morphology, density, and key protein phosphorylation were assessed. In experiment II (based on the findings from experiment I), ovarian tissues (n=10 animals; 270 ovarian fragments) were encapsulated with 10 FG, cryopreserved, and in vitro cultured under static or non-static systems for 7 days followed by similar follicle quality assessments. RESULTS: In experiment I, the combination of 10 FG encapsulation/slow freezing led to greater post-thawed follicle quality than in the control group, as shown by follicle viability (66.9%±2.2% vs. 61.5%±3.1%), normal follicle morphology (62.2%±2.1% vs. 55.2%±3.5%), and the relative band intensity of vascular endothelial growth factor protein phosphorylation (0.58±0.06 vs. 0.42±0.09). Experiment II demonstrated that hydrogel encapsulation promoted follicle survival and maintenance of follicle development regardless of the culture system when compared to fresh controls. CONCLUSION: These results provide a better understanding of the role of hydrogel encapsulation and culture systems in ovarian tissue cryopreservation and follicle quality outcomes using an animal model, paving the way for optimized approaches to human fertility preservation.

Effects of vaginal administration of conjugated estrogens tablet on sexual function in postmenopausal women with sexual dysfunction: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Female sexual dysfunction (FSD) is prevalent in women with genitourinary syndrome of menopause (GSM). Vaginal estrogen is effective GSM treatment. This study was primarily aimed to evaluate the effects of vaginal administration of conjugated estrogens tablet on postmenopausal FSD using the Female Sexual Function Index (FSFI). Secondary aims were to evaluate vaginal pH, Vaginal Maturation Value (VMV), Normal Flora Index (NFI) and Most Bothersome Symptoms (MBS) changes. METHODS: A double-blind trial was conducted in postmenopausal women with FSD (FSFI ≤26.55). Sixty-seven participants were randomized into two arms; vaginally administered conjugated estrogens tablet (0.625 mg, daily for 3 weeks then twice weekly for 9 weeks, n = 33), or placebo (n = 34). RESULTS: There was no significant improvement of FSFI observed in estrogens arm compared to placebo in each domain and overall index (p = 0.182). The estrogens significantly improved vaginal pH and VMV, toward more acidity (p = < 0.001), higher VMV (p = < 0.001) and more superficial cells (p = < 0.001). We observed no significant difference in NFI and MBS between arms (p = 0.282, 0.182). CONCLUSION: We found no significant changes in FSFI, NFI, and MBS, but significant improvement in vaginal pH and VMV in postmenopausal women with FSD treated with vaginally administered conjugated estrogens tablet. Few side-effects were reported. TRIAL REGISTRATION: Thai Clinical Trial Registry identification number TCTR20180219001 , prospectively registered since 2018-02-19 11:33:21.

Risk Factors of Ectopic Pregnancy in Women Undergoing In Vitro Fertilization and Embryo Transfer (IVF-ET).

Objective: To identify risk factors associated with ectopic pregnancy (EP) in women undergoing assisted reproductive technology (ART). Material and Method: A retrospective study was conducted among pregnant women after in vitro fertilization and embryo transfer (IVF-ET) in an assisted conception unit of a university hospital between 1994 and 2013. The factors evaluated included the use of donor oocyte, use of intracytoplasmic sperm injection (ICSI), stage of embryo, number of embryos transferred, and fresh or frozen-thawed cycle. Results: One thousand three hundred eighty five pregnancies were identified of which 29 were ectopic pregnancies. Embryo transfer (ET) in fresh cycle significantly increased risk for EP compared with frozen-thawed cycle (p = 0.005). Day-5 ET also significantly increased higher EP risk than day-3 ET (p = 0.041). Three or more embryos transfer (p = 0.085), use of donor oocyte (p = 0.999), and use of ICSI (p = 0.246) did not significantly influence EP risk. Conclusion: Embryo transfer in fresh cycle and day-5 embryo transfer significantly increased EP risk. More patients and embryo characteristics are necessary to be studied to identify more valid predictors.