Comparing Letrozole Alone Versus Letrozole Plus Levothyroxine for Helping Women With PCOS and Subclinical Hypothyroidism to Ovulate and Achieve Pregnancy

What this Trial Is About

Researchers are evaluating the effectiveness of letrozole alone versus letrozole combined with levothyroxine for inducing ovulation in infertile women who have both polycystic ovary syndrome PCOS and subclinical hypothyroidism. The study aims to determine if adding levothyroxine improves ovulation rates, pregnancy rates, and live birth rates compared to letrozole alone. The trial is randomized and involves women aged 20 to 40 years with specific diagnostic criteria for PCOS and subclinical hypothyroidism. Participants are assigned to one of two groups. The first group receives letrozole starting at 2.5 mg daily from day 3 to 7 of their menstrual cycle, with doses increasing up to 7.5 mg if ovulation does not occur, for a maximum of six months or until pregnancy. The second group receives the same letrozole dosing plus daily levothyroxine starting at 25 mcg, adjusted based on thyroid-stimulating hormone TSH levels to reach normal ranges. Both groups have their ovulation monitored by follicular ultrasound and progesterone levels, and treatment compliance is tracked by pill counts and diaries. During the study, participants attend regular visits for ovulation assessment at the end of each menstrual cycle, with up to six cycles evaluated. Pregnancy and live birth outcomes are followed for about one year. Researchers also monitor menstrual regularity, miscarriage rates, and side effects throughout the study period. If pregnancy occurs, participants receive routine antenatal care. Safety is closely observed, and participants are followed for any multiple pregnancies. The total duration of participation can be up to one year, including treatment and follow-up.

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