An interventional study of Letrozole 2.5mg and Levothyroxine 25 Mcg (0.025 Mg) Oral Tablet in PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Subclinical Hypothyroidism and Female Infertility, sponsored by Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy · Not applicable, Interventional, and Treatment
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Participants randomized to letrozole group will take 5mg tablets orally daily for 5 days starting on day 3 of cycle. Dose can be adjusted up to 7.5mg based on ovulation response, maintained for subsequent cycles. Treatment continues for up to 6 ovulatory cycles or until pregnancy occurs. Ovulation assessed by follicular monitoring and progesterone. Compliance monitored by pill counts and diary. Routine antenatal care if pregnant. Adverse effects monitored per guidelines. Participants followed for multiple pregnancies. Tablets taken at same time each day. Maximum treatment period is 6 months.
Drug: Letrozole 2.5mg
Participants randomized to this group will take letrozole tablets at same dose and schedule as letrozole only group. In addition, they will take levothyroxine tablets orally once daily. Levothyroxine dose will start at 25mcg and be titrated based on TSH level, with a target TSH in the normal range. Participants will take levothyroxine at approximately same time each day. Letrozole dosing and schedule as described for other group. Treatment continues for up to 6 ovulatory cycles or until pregnancy occurs. Ovulation assessed by follicular monitoring and progesterone. Compliance monitored by pill counts, TSH levels and diary. Routine antenatal care if pregnant. Adverse effects monitored per guidelines. Participants followed for multiple pregnancies. Maximum treatment period is 6 months.
Drug: Letrozole 2.5mg · Drug: Levothyroxine 25 Mcg (0.025 Mg) Oral Tablet
Participants will receive 2.5mg letrozole tablets orally daily for 5 days starting on day 3 of menstrual cycle. The 2.5mg dose will be maintained for at least the first 3 cycles. If no ovulation after 3 cycles, dose cautiously increased up to 7.5mg maximum. Once minimum ovulation dose determined, it will be continued for up to 6 cycles total or until pregnancy occurs. Compliance monitored by pill counts and diary. Ovulation assessed by follicular monitoring and progesterone levels. Routine antenatal care if pregnant. Adverse effects monitored and managed per guidelines. Participants followed for multiple pregnancies. Maximum treatment duration is 6 ovulatory cycles or 6 months. Tablets taken at same time each day.
Participants will take letrozole at same doses as letrozole only group. Also receive levothyroxine starting at 25mcg orally once daily, titrated by 25mcg every 4 weeks to reach normal TSH, maximum 100mcg daily. Once appropriate dose determined to normalize TSH, it is maintained throughout treatment period. Compliance monitored by pill counts, TSH levels, and diary. Treatment continues for up to 6 ovulatory cycles or until pregnancy, whichever is first, maximum 6 months. Ovulation assessed by monitoring and progesterone. Routine antenatal care if pregnant. Adverse effects monitored and managed per guidelines. Participants followed for multiple pregnancies. Letrozole and levothyroxine taken daily at same time. All other procedures same as letrozole only group.
Also known as: levothyroxine 25
Pregnancy rate
Biochemical evidence of pregnancy by positive urine or serum β-hCG test.
Time frame: Assessed at the end of each cycle. the cycles are 6. Each cycle is 28 days.
Live birth rate
The number of deliveries that resulted in a live born baby, documented by hospital delivery records.
Time frame: Through study completion average 1 year.
Ovulation rate
Evidence of ovulation by ultrasound monitoring of dominant follicle development and serum progesterone level \> 3 ng/mL in mid-luteal phase.
Time frame: Assessed at the end of each cycle. the cycles are 6. Each cycle is 28 days.
Miscarriage rate
Loss of clinical pregnancy before 20 weeks gestation, confirmed by ultrasound or histopathology.
Time frame: Through study completion average 1 year.
Menstrual regularity
Normal ovulatory menstrual cycles defined as cycle length 21-35 days.
Time frame: Through study completion average 1 year.
Side effects
Participant reports of adverse effects of letrozole or levothyroxine, graded per standard criteria.
Time frame: Through study completion average 1 year.
Plan to share: No — To protect participant confidentiality, individual-level data from this study will not be made publicly available. However, de-identified aggregated data and results can be shared with other researchers upon request after publication. Any data provided will be limited, non-identifiable, and subject to a data use agreement to ensure participant privacy. Only select excerpts needed to validate findings will be shared under approved research objectives. The investigators reserve the right to reject requests that may compromise anonymity. We aim to promote transparency through controlled data access rather than public availability of the full dataset due to re-identification risks for participants.
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Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy