NCT06041204 Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
| NCT ID | NCT06041204 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy |
| Condition | PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-05-06 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2021-05-06 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Contact & Investigator
Muhamed Alhagrasy, M.D.
PRINCIPAL INVESTIGATOR
Al-Azhar University
Frequently Asked Questions
Who can join the NCT06041204 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06041204 currently recruiting?
Yes, NCT06041204 is actively recruiting participants. Contact the research team at MuhamedAhmed.216@azhar.edu.eg for enrollment information.
Where is the NCT06041204 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06041204 clinical trial?
NCT06041204 is sponsored by Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy. The principal investigator is Muhamed Alhagrasy, M.D. at Al-Azhar University. The trial plans to enroll 200 participants.