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Clinical Trial Name - Letrozole Versus Clomifene Citrate for Ovulation Induction
| Original Study ID : RD-5103-015-06 |
| Secondary ID : EudraCT No: 2006-006514-15 |
| NCT ID : NCT00478504 |
| Brief Title : Letrozole Versus Clomifene Citrate for Ovulation Induction |
| Official Title : Double Blind Cross-Over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome |
| Brief Summary : The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome. |
| Source : Derby Hospitals NHS Foundation Trust |
| Overall Status : Recruiting |
| Start Date : May 2007 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study |
| Enrollment : 212 |
| Verification Date : May 2007 |
| First Received Date : May 23, 2007 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: 1. Age: 18 - 39 2. BMI < 36 3. Infertility due to anovulation 4. PCOS: At least two of the following diagnostic criteria of: 1. Oligo/amenorrhoea 2. Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence 3. USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml) 5. No recent (within 6 months) treatment for induction of ovulation 6. Normal semen analysis (WHO 1999) 7. Proven patency of at least one Fallopian tube Exclusion Criteria: 1. Inability to give informed consent 2. Contraindication to letrozole or clomifene citrate 3. Absence of any inclusion criteria |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : 39 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Derby City General Hospital |
| Status : Recruiting |
| City : Derby |
| State : Derbyshire |
| Zip Code : DE22 3NE |
| Country : United Kingdom |
| OutComes |
| Primary OutComes |
| Measure : Pregnancy rate |
| Secondary OutComes |
| Measure : 1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness |
| Interventions |
| Type : Drug |
| Name : Letrozole |
| Type : Drug |
| Name : Clomifene citrate |
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