NCT06041204Recruiting
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
Letrozole Alone vs. Letrozole Plus Levothyroxine for Ovulation Induction in Infertile Women With Both (Polycystic Ovary Syndrome) PCOS and Sub-clinical Hypothyroidism.
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 5 Sept 2023
- Start date
- May 2021
- Primary completion date
- May 2026
- Lead sponsor
- Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
- NCT number
- NCT06041204
What you commit to
- Study type: Interventional
- Planned participants: 200
- From May 2021 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of any type of congenital adrenal hyperplasia
- Previous use of letrozole or levothyroxine in past 6 months
Other illness
- Known thyroid disease or on thyroid medications
- 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)
- History of deep vein thrombosis or thromboembolic events
Lab values
- Uncontrolled diabetes (HbA1C \>8%)
Other
- Abnormal thyroid function tests other than subclinical hypothyroidism
- Hyperprolactinemia
- Presence of other causes of infertility such as:
- Any contraindication to letrozole or levothyroxine
- Current or suspected pregnancy
- Breastfeeding
- Inability to comply with treatment and follow-up procedures
Who the study is looking for
- 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
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al-Hussein University Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.