Letrozole Versus Clomifene Citrate for Ovulation Induction
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...
Brief Summary
Official Title: “Double Blind Cross-Over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Letrozole
- Drug: Clomifene citrate
Outcome Measures for this Clinical Trial
Primary Measures
- Pregnancy rate
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 39 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Derby Hospitals NHS Foundation Trust Other
Overall Clinical Trial Officials and Contacts
Saad Amer, MD, MRCOG Principal Investigator University of Nottingham and Derby Hospitals NHS foundation Trust
Overall Contact: Saad Amer, MD, MRCOG +44(1332)724612 saad.amer@nottingham.ac.uk
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00478504
Study ID Number: RD-5103-015-06
ClinicalTrials.gov Identifier: NCT00478504
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00478504
