Clinical Research Directory

Endometrial Response in Polyendocrine Metabolic Ovarian Syndrome (PMOS) Treated With Letrozole Alone or With Added Estradiol Valerate

Polyendocrine Metabolic Ovarian Syndrome (PMOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.

Effect of Zinc Supplementation on Insulin Resistance and Clinical Features in Women With Polyendocrine Metabolic Ovarian Syndrome.

Polyendocrine Metabolic Ovarian Syndrome (PMOS) is the most common endocrinopathy in women of reproductive age, and is mechanistically anchored in insulin resistance (IR), and drives the downstream cascade of hyperandrogenism, anovulation, dyslipidaemia and long-term type 2 diabetes risk. South Asian women -including Bangladeshi women - develop IR at lower BMI thresholds than other populations and simultaneously carry one of the world's highest burdens of zinc deficiency (57% of non-pregnant non-lactating women). Zinc is structurally required for pancreatic β-cell insulin synthesis, modulates insulin-receptor signaling and PI3K/Akt-mediated glucose uptake, and acts as a cofactor for Cu/Zn-superoxide dismutase, suppressing the oxidative stress and NF-κB-driven inflammation that perpetuate IR in PMOS. Despite this strong mechanistic rationale, no randomised trial of zinc supplementation in PMOS has been conducted in any South Asian population. To evaluate the effect of 12 weeks of oral zinc supplementation, as adjunct to standard conventional therapy, on insulin resistance (HOMA-IR) and on clinical and biochemical features of PMOS in Bangladeshi women. A randomised, double-blind, placebo-controlled trial will be conducted at the Department of Pharmacology in collaboration with the Department of Obstetrics \& Gynaecology, Bangladesh Medical University (BMU), Dhaka. Seventy four newly diagnosed women with PMOS (Rotterdam / 2023 ESHRE criteria), aged 18-45 years, will be randomised 1:1 to receive elemental zinc 50 mg/day or an identical-appearing placebo, in addition to standard conventional therapy, for 12 weeks. The primary outcome is change in HOMA-IR from baseline to 12 weeks. Secondary outcomes include change in serum zinc, serum triglycderide, biomarker of oxidative stress (serum malondialdehyde), modified Ferriman-Gallwey (mFG) hirsutism score, BMI, and menstrual regularity. Between-arm comparisons will use unpaired t-tests / Mann-Whitney U; within-arm changes by paired t-tests; categorical outcomes by χ²; and the relationship between change in serum zinc and changes in HOMA-IR, mFG and androgen markers by Pearson / Spearman correlation. In conclusion, combining zinc supplementation with the conventional treatment might be potentially have a safe, low cost, substantial impact on insulin resistance, lipid profile, oxidative stress and hormonal measures in patients with PMOS.

Comparison of Clomiphene Alone Versus Clomiphene Plus Sildenafil for Ovulation in Women With Polycystic Ovary Syndrome

The goal of this randomized clinical trial is to compare the effectiveness of clomiphene citrate alone with clomiphene citrate combined with sildenafil citrate for inducing ovulation and achieving pregnancy in women with polycystic ovary syndrome (PCOS) who have difficulty becoming pregnant. The main question the study aims to answer is: Does adding sildenafil citrate to clomiphene citrate increase the chance of ovulation and pregnancy compared with clomiphene citrate alone in women with PCOS? The study will include 98 women aged 18-45 years with PCOS and a history of difficulty achieving pregnancy for more than 2 years. Participants will be randomly assigned to one of two groups. * Participants in Group A will receive clomiphene citrate 100 mg once daily from days 3-7 of the menstrual cycle, plus sildenafil citrate 25 mg twice daily from days 8-12. * Participants in Group B will receive clomiphene citrate 100 mg once daily from days 3-7, plus a placebo twice daily from days 8-12. Treatment will be given for 12 weeks. Participants will be assessed for ovulation, pregnancy, and endometrial thickness. Ovulation will be assessed using transvaginal ultrasound and/or a blood progesterone test. Pregnancy will be assessed using a urine pregnancy test and/or ultrasound. The primary hypothesis is that women receiving clomiphene citrate plus sildenafil citrate will have a higher rate of pregnancy than women receiving clomiphene citrate alone. The study will also determine whether adding sildenafil improves ovulation and endometrial thickness.