Actively Recruiting
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
Led by Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy · Updated on 2025-09-03
200
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 40 years
- Body mass index (BMI) between 18 and 35 kg/m2
- Diagnosis of PCOS based on Rotterdam consensus and ESHRE/ASRM 2018 criteria
- Presence of oligo- and/or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries visible on ultrasound
- Subclinical hypothyroidism with TSH between 5 and 10 mIU/L and normal free T4
- Infertility lasting at least 1 year
- Intact ovaries and uterus confirmed by exam and imaging
- Normal semen analysis in male partner
- No tubal or peritoneal infertility factors
- Using effective contraception if not trying to conceive
- Willing and able to give informed consent
You will not qualify if you...
- Known thyroid disease or current use of thyroid medication
- Abnormal thyroid function tests other than subclinical hypothyroidism
- Hyperprolactinemia
- Other infertility causes such as moderate to severe male factor, bilateral tubal blockage, peritoneal factors, stage III-IV endometriosis
- Ovarian failure or insufficiency (high FSH or low AMH)
- Previous diagnosis of any congenital adrenal hyperplasia
- Uncontrolled diabetes with HbA1C above 8%
- History of deep vein thrombosis or thromboembolic events
- Contraindications to letrozole or levothyroxine
- Use of letrozole or levothyroxine in the past 6 months
- Current or suspected pregnancy
- Breastfeeding
- Unable to comply with treatment or follow-up procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Al-Hussein University Hospital
Cairo, Egypt, 11633
Actively Recruiting
Research Team
M
Muhamed Alhagrasy, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here