Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
Recruiting · NCT06041204 · Interventional (participants receive a specific treatment) · Lead sponsor: Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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):
- ligo- 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 is running
1 location listed.
- Al-Hussein University Hospital - Cairo, Egypt