Status:
RECRUITING
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
Lead Sponsor:
Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
Conditions:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Subclinical Hypothyroidism
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief 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....
Eligibility Criteria
Inclusion
- Age between 20-40 years
- BMI between 18-35 kg/m2
- Meet diagnostic criteria for PCOS based on the Rotterdam consensus criteria and ESHRE/ASRM modifications (2018):
- Oligo- and/or anovulation Clinical and/or biochemical signs of hyperandrogenism Polycystic ovaries on ultrasound
- Subclinical hypothyroidism defined as TSH level between 5-10 mIU/L with normal free T4
- Infertility duration ≥ 1 year
- Intact ovaries and uterus, confirmed by physical exam and imaging
- Normal semen analysis in male partner
- No tubal or peritoneal factor contributing to infertility
- Effective contraception if not attempting conception
- Willing and able to provide informed consent
Exclusion
- Known thyroid disease or on thyroid medications
- Abnormal thyroid function tests other than subclinical hypothyroidism
- Hyperprolactinemia
- Presence of other causes of infertility such as:
- Moderate to severe male factor infertility Bilateral tubal occlusion or peritoneal factors Stage III-IV endometriosis Ovarian failure or insufficiency (high FSH or low AMH)
- Previous diagnosis of any type of congenital adrenal hyperplasia
- Uncontrolled diabetes (HbA1C \>8%)
- History of deep vein thrombosis or thromboembolic events
- Any contraindication to letrozole or levothyroxine
- Previous use of letrozole or levothyroxine in past 6 months
- Current or suspected pregnancy
- Breastfeeding
- Inability to comply with treatment and follow-up procedures
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06041204
Start Date
May 6 2021
End Date
June 28 2026
Last Update
September 3 2025
Active Locations (1)
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1
Al-Hussein University Hospital
Cairo, Egypt, 11633