Female Infertility Clinical Trial
Official title:
Letrozole Alone vs. Letrozole Plus Levothyroxine for Ovulation Induction in Infertile Women With Both (Polycystic Ovary Syndrome) PCOS and Sub-clinical Hypothyroidism.
NCT number | NCT06041204 |
Other study ID # | Gyne2021 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2021 |
Est. completion date | May 28, 2025 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 28, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Al-Hussein University Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pregnancy rate | Biochemical evidence of pregnancy by positive urine or serum ß-hCG test. | Assessed at the end of each cycle. the cycles are 6. Each cycle is 28 days. | |
Primary | Live birth rate | The number of deliveries that resulted in a live born baby, documented by hospital delivery records. | Through study completion average 1 year. | |
Secondary | Ovulation rate | Evidence of ovulation by ultrasound monitoring of dominant follicle development and serum progesterone level > 3 ng/mL in mid-luteal phase. | Assessed at the end of each cycle. the cycles are 6. Each cycle is 28 days. | |
Secondary | Miscarriage rate | Loss of clinical pregnancy before 20 weeks gestation, confirmed by ultrasound or histopathology. | Through study completion average 1 year. | |
Secondary | Menstrual regularity | Normal ovulatory menstrual cycles defined as cycle length 21-35 days. | Through study completion average 1 year. | |
Secondary | Side effects | Participant reports of adverse effects of letrozole or levothyroxine, graded per standard criteria. | Through study completion average 1 year. |
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