Comparing Clomid and Letrozole for Ovulation Induction in PCOS
A RCT Comparing the Effectiveness of a Combination Therapy of Lezra and Clomid Versus Lezra Alone for Inducing Ovulation in Women Diagnosed With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
This study is testing whether using letrozole alone or with clomid can help women with PCOS who haven't responded to clomid alone to ovulate better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | HITEC-Institute of Medical Sciences Academic / other |
| Locations | 1 site (Rawalpindi, Punjab) |
| Trial ID | NCT06813118 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of letrozole alone versus a combination of clomiphene citrate and letrozole for inducing ovulation in women with polycystic ovarian syndrome (PCOS) who are resistant to clomiphene citrate. Participants will undergo transvaginal ultrasound to monitor the development of mature follicles and assess endometrial thickness. The study will include women aged 20-40 years with a history of PCOS and will exclude those with certain hormonal imbalances or male factor infertility. The goal is to determine which treatment approach is more effective for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20-40 with a diagnosis of PCOS who have not ovulated after six cycles of clomiphene citrate.
Not a fit: Patients with premature ovarian insufficiency, male factor infertility, or hormonal disorders such as hypothyroidism or hyperprolactinemia 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 who do not respond to standard ovulation induction therapies.
How similar studies have performed: Previous studies have shown that letrozole can be an effective alternative for ovulation induction in women with PCOS, suggesting that this approach may have a solid foundation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women of 20-40 years with a history of PCOS and resistant to CC Exclusion Criteria: * Premature ovarian insufficiency * Husband has oligo azoospermia * Hypothyroidism * Hyperprolactinemia
Where this trial is running
Rawalpindi, Punjab
- HIT Hospital — Rawalpindi, Punjab, Pakistan (Recruiting)
Study contacts
- Principal investigator: Rukhsana Shaheen Afzal, MBBS,FCPS — HITEC-Institute of Medical Sciences
- Study coordinator: Rukhsana Shaheen Afzal, MBBS,FCPS
- Email: dr_rukh2006@yahoo.com
- Phone: 03339014943
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.