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

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

May 6, 2021

Primary Completion Date

May 30, 2026

Study Completion Date

June 28, 2026

Conditions
PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesSubclinical HypothyroidismFemale Infertility
Interventions
DRUG

Letrozole 2.5mg

Participants will receive 2.5mg letrozole tablets orally daily for 5 days starting on day 3 of menstrual cycle. The 2.5mg dose will be maintained for at least the first 3 cycles. If no ovulation after 3 cycles, dose cautiously increased up to 7.5mg maximum. Once minimum ovulation dose determined, it will be continued for up to 6 cycles total or until pregnancy occurs. Compliance monitored by pill counts and diary. Ovulation assessed by follicular monitoring and progesterone levels. Routine antenatal care if pregnant. Adverse effects monitored and managed per guidelines. Participants followed for multiple pregnancies. Maximum treatment duration is 6 ovulatory cycles or 6 months. Tablets taken at same time each day.

DRUG

Levothyroxine 25 Mcg (0.025 Mg) Oral Tablet

Participants will take letrozole at same doses as letrozole only group. Also receive levothyroxine starting at 25mcg orally once daily, titrated by 25mcg every 4 weeks to reach normal TSH, maximum 100mcg daily. Once appropriate dose determined to normalize TSH, it is maintained throughout treatment period. Compliance monitored by pill counts, TSH levels, and diary. Treatment continues for up to 6 ovulatory cycles or until pregnancy, whichever is first, maximum 6 months. Ovulation assessed by monitoring and progesterone. Routine antenatal care if pregnant. Adverse effects monitored and managed per guidelines. Participants followed for multiple pregnancies. Letrozole and levothyroxine taken daily at same time. All other procedures same as letrozole only group.

Trial Locations (1)

11633

RECRUITING

Al-Hussein University Hospital, Cairo

All Listed Sponsors
lead

Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

OTHER