drugset / Trial / NCT06041204

Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism

NCT06041204

RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this randomized controlled trial is to compare letrozole alone versus letrozole plus levothyroxine for ovulation induction in infertile women with both PCOS and subclinical hypothyroidism. The main questions it aims to answer are: Is letrozole plus levothyroxine superior to letrozole alone in achieving ovulation in these patients? Does combining levothyroxine with letrozole lead to higher pregnancy and live birth rates compared to letrozole alone? Participants will be randomized into two groups: Group 1 will receive letrozole only, starting at 2.5 mg daily from day 3 to 7 of the menstrual cycle. The dose will be increased up to 7.5 mg if no ovulation occurs, for a maximum treatment period of 6 months or until pregnancy is achieved. Group 2 will receive letrozole at the same doses as group 1 plus 25 mcg levothyroxine daily.

Timeline

Start
2021-05-06
Primary completion
2026-05-30
Completion
2026-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Levothyroxine Other / unclassified 25 ug Oral