Comparing letrozole alone versus letrozole with levothyroxine for women with PCOS and subclinical hypothyroidism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of letrozole alone compared to a combination of letrozole and levothyroxine for inducing ovulation in infertile women diagnosed with both polycystic ovary syndrome (PCOS) and subclinical hypothyroidism. Participants will be randomly assigned to receive either letrozole only or letrozole plus levothyroxine for a maximum of six months or until pregnancy is achieved. The study seeks to determine if the addition of levothyroxine improves ovulation rates and leads to higher pregnancy and live birth rates.

Why it matters

Who can join: the full rules

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

Where it's running

• Al-Hussein University Hospital
  Cairo, Egypt Recruiting

Study contacts

• Principal investigator: Muhamed Alhagrasy, M.D. — Al-Azhar University
• Study coordinator: Muhamed Alhagrasy, M.D.
• Email: MuhamedAhmed.216@azhar.edu.eg
• Phone: 01017313413

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.