Letrozole Versus Clomifene Citrate for Ovulation Induction
Information source: Derby Hospitals NHS Foundation Trust
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility; Polycystic Ovarian Syndrome
Intervention: Letrozole (Drug); Clomifene citrate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Derby Hospitals NHS Foundation Trust Official(s) and/or principal investigator(s):
Saad Amer, MD, MRCOG, Principal Investigator, Affiliation: University of Nottingham and Derby Hospitals NHS foundation Trust
Overall contact:
Saad Amer, MD, MRCOG, Phone: +44(1332)724612, Email: saad.amer@nottingham.ac.uk
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.
Clinical Details
Official title: Double Blind Cross-Over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Pregnancy rate
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 39 Years.
Gender(s): Female.
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
Locations and Contacts
Saad Amer, MD, MRCOG, Phone: +44(1332)724612, Email: saad.amer@nottingham.ac.uk
Derby City General Hospital, Derby, Derbyshire DE22 3NE, United Kingdom; Recruiting
Saad Amer, MD, MRCOG, Phone: +44(1332)724612, Email: saad.amer@nottingham.ac.uk
Additional Information
Starting date: May 2007
Last updated: May 23, 2007
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