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: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Letrozole
• Drug: Clomifene citrate

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

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

Lead Sponsor: Derby Hospitals NHS Foundation Trust

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

Information obtained from ClinicalTrials.gov on September 04, 2008

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