Testing letrozole with or without levothyroxine for infertile women with PCOS and hypothyroidism
Compares two treatments to help women with PCOS and mild thyroid problems ovulate.
Plain-language title generated from the registry record
Registry title: Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
Key facts
- Where
- Cairo, EgyptSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 20-40 who have both PCOS and mild underactive thyroid (subclinical hypothyroidism) and have been unable to get pregnant for at least 1 year.
- Age
- 20 to 40 years. BMI between 18 and 35 kg/m2.
- Sex
- Women only.
- Disease stage
- PCOS by the Rotterdam criteria (irregular or no ovulation, signs of high male hormones, polycystic ovaries on ultrasound). Subclinical hypothyroidism with TSH between 5-10 mIU/L and normal free T4. Infertility for 1 year or more.
- Earlier treatment
- No letrozole or levothyroxine in the past 6 months. Not on any thyroid medicine.
- Biomarker or test result
- TSH between 5-10 mIU/L with normal free T4.
Main reasons for not taking part
- Known thyroid disease, or other abnormal thyroid tests
- High prolactin
- Other causes of infertility (for example blocked tubes, stage III-IV endometriosis, ovarian failure, moderate to severe male factor)
- Uncontrolled diabetes (HbA1C above 8% (64 mmol/mol))
- Current or suspected pregnancy, or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 40 years old?
Source: NCT06041204, who can take part
Where in Egypt
- Al-Hussein University HospitalCairo, EgyptContact: Muhamed A Alhagrasy, M.D.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
- Trial code
- NCT06041204
- Record updated
- 3 September 2025
- Original description
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:Read full original descriptionShow less
Letrozole Alone vs. Letrozole Plus Levothyroxine for Ovulation Induction in Infertile Women With Both (Polycystic Ovary Syndrome) PCOS and Sub-clinical Hypothyroidism.
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.
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: Previous diagnosis of any type of congenital adrenal hyperplasia; Previous use of letrozole or levothyroxine in past 6 months; 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; Uncontrolled diabetes (HbA1C >8%); 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.