Combining Letrozole and Clomiphene Citrate for PCOS Infertility Treatment
Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Control Trial
This study is testing if using letrozole together with clomiphene citrate can help women with PCOS who are struggling to get pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Egymedicalpedia Industry-sponsored |
| Locations | 1 site (Cairo, Abbasia) |
| Trial ID | NCT06507332 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining letrozole and clomiphene citrate compared to using letrozole alone in treating infertility in women with polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder that often leads to anovulatory infertility. The study aims to evaluate whether the combination of these two medications can improve ovulation rates and pregnancy outcomes. Participants will be women diagnosed with PCOS who have been unable to conceive after a specified period of regular unprotected intercourse.
Who should consider this trial
Good fit: Ideal candidates for this study are women under 35 years old with a diagnosis of infertility and PCOS based on the Rotterdam criteria.
Not a fit: Patients with unexplained infertility or other conditions causing chronic anovulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance ovulation induction and increase pregnancy rates in women with PCOS.
How similar studies have performed: Previous studies have shown varying success with similar ovulation induction approaches, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of infertility, defined as the inability of couple to achieve a pregnancy after 12 months of regular timed unprotected intercourse in women \<35 years of age or after 6 months in women \>35 years of age. * Diagnosis of PCOS based on the Rotterdam criteria, including two of the following three findings: oligomenorrhea or chronic anovulation, hyperandrogenism (clinical or laboratory), and polycystic ovary(ies) on ultrasound . * Normal HSG * Normal semen analysis. * Has capacity to participate in the study. Exclusion Criteria: * Unexplained infertility. * Other conditions that can cause chronic anovulation and androgen excess such as hyperthyroidism by thyroid profile. * congenital adrenal hyperplasia * Cushing * Untreated hyperprolactinemia. * Medical conditions not well controlled or contraindicated to get pregnant with it like (uncontrolled diabetes mellitus, hypertension) . * endometrial hyperplasia/cancer * Allergy or contraindications to letrozole or CC. (by history)
Where this trial is running
Cairo, Abbasia
- Ain Shams University Hospitals — Cairo, Abbasia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Adel Mousa, MSC
- Email: sedyyasedy@gmail.com
- Phone: +201093429998
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.