Comparing letrozole alone versus letrozole with levothyroxine for women with 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.
This study is testing if adding levothyroxine to letrozole helps women with PCOS and low thyroid function get pregnant more effectively than letrozole alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06041204 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20-40 with a BMI between 18-35 who have been diagnosed with PCOS and subclinical hypothyroidism and have been infertile for at least one year.
Not a fit: Patients with known thyroid disease, those on thyroid medications, or those with other significant causes of infertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women with PCOS and subclinical hypothyroidism who are struggling with infertility.
How similar studies have performed: While there have been studies on the individual treatments, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cairo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.