Actively Recruiting
Letrozole Alone vs. Letrozole Plus Levothyroxine for Ovulation Induction in Infertile Women With PCOS and Subclinical Hypothyroidism
Led by Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy · Updated on 2025-09-03
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of letrozole alone versus letrozole combined with levothyroxine for inducing ovulation in infertile women who have both polycystic ovary syndrome (PCOS) and subclinical hypothyroidism. The study aims to determine if adding levothyroxine improves ovulation rates, pregnancy rates, and live birth rates compared to letrozole alone. The trial is randomized and involves women aged 20 to 40 years with specific diagnostic criteria for PCOS and subclinical hypothyroidism. Participants are assigned to one of two groups. The first group receives letrozole starting at 2.5 mg daily from day 3 to 7 of their menstrual cycle, with doses increasing up to 7.5 mg if ovulation does not occur, for a maximum of six months or until pregnancy. The second group receives the same letrozole dosing plus daily levothyroxine starting at 25 mcg, adjusted based on thyroid-stimulating hormone (TSH) levels to reach normal ranges. Both groups have their ovulation monitored by follicular ultrasound and progesterone levels, and treatment compliance is tracked by pill counts and diaries. During the study, participants attend regular visits for ovulation assessment at the end of each menstrual cycle, with up to six cycles evaluated. Pregnancy and live birth outcomes are followed for about one year. Researchers also monitor menstrual regularity, miscarriage rates, and side effects throughout the study period. If pregnancy occurs, participants receive routine antenatal care. Safety is closely observed, and participants are followed for any multiple pregnancies. The total duration of participation can be up to one year, including treatment and follow-up.
CONDITIONS
Brief Title
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged between 20 and 40 years
- Body mass index (BMI) between 18 and 35 kg/m2
- Diagnosed with PCOS based on the Rotterdam consensus criteria and ESHRE/ASRM modifications (2018)
- Subclinical hypothyroidism defined as TSH level between 5-10 mIU/L with normal free T4
- Infertility lasting at least 1 year
- Intact ovaries and uterus confirmed by exam and imaging
- Normal semen analysis in male partner
- No tubal or peritoneal cause of infertility
- Using effective contraception if not attempting to conceive
- Willing and able to provide informed consent
You will not qualify if you...
- Known thyroid disease or current thyroid medication use
- Abnormal thyroid tests other than subclinical hypothyroidism
- Hyperprolactinemia
- Moderate to severe male infertility
- Bilateral tubal blockage or peritoneal infertility factors
- Stage III-IV endometriosis
- Ovarian failure or insufficiency (high FSH or low AMH)
- Previous diagnosis of congenital adrenal hyperplasia
- Uncontrolled diabetes with HbA1C >8%
- History of deep vein thrombosis or blood clots
- Contraindications to letrozole or levothyroxine
- Use of letrozole or levothyroxine in the past 6 months
- Current or suspected pregnancy
- Breastfeeding
- Unable to comply with treatment and follow-up procedures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months or 6 ovulatory cycles
Participants receive letrozole tablets daily for 5 days starting on day 3 of their menstrual cycle. Dose may be increased if ovulation does not occur after 3 cycles, up to a maximum of 7.5mg daily. Participants in the combination group also take levothyroxine once daily, with dose adjusted every 4 weeks to normalize TSH levels. Treatment continues for up to 6 ovulatory cycles or until pregnancy occurs, whichever is first.
Up to 6 monthly visits for ovulation assessment and dose adjustments
Trial Site Locations
Total: 1 location
1
Al-Hussein University Hospital
Cairo, Egypt, 11633
Actively Recruiting
Research Team
M
Muhamed Alhagrasy, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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