A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome

What this Trial Is About

Researchers are evaluating the effect of vitamin D supplementation on ovulation rates in women with polycystic ovary syndrome (PCOS). This randomized, double-blind controlled trial focuses on women diagnosed with PCOS by the Rotterdam criteria who experience irregular menstrual cycles and anovulation. The study aims to assess ovulation and other reproductive, endocrine, and metabolic outcomes over one year of treatment. Participants will be randomly assigned to either a vitamin D group or a placebo group. The vitamin D group will take 50,000 IU weekly for 4 weeks, then 50,000 IU every two weeks for 52 weeks. Participants who remain anovulatory after 6 months in both groups will receive a 6-month course of letrozole to induce ovulation. The placebo group will receive tablets that look like vitamin D but contain no active ingredient. During the study, participants will undergo transvaginal ultrasounds and blood tests to monitor ovulation, hormone levels, and other health indicators. Researchers will track ovulation rate as the primary outcome, along with pregnancy rates, live births, metabolic measures, and body measurements for up to 12 months. The study includes safety monitoring related to vitamin D levels and calcium. Total participation lasts about one year.

Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome