Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome

University of Nottingham1 site in 1 country159 target enrollmentMay 2007

ConditionsInfertility Polycystic Ovarian Syndrome

InterventionsClomifene citrate Letrozole

DrugsLetrozole Clomifene citrate

Overview

Phase: Phase 4
Intervention: Clomifene citrate
Conditions: Infertility
Sponsor: University of Nottingham
Enrollment: 159
Locations: 1
Primary Endpoint: Pregnancy rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

September 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

University of Nottingham

Responsible Party

Principal Investigator

Saad Amer

Associate Professor

University of Nottingham

Eligibility Criteria

Inclusion Criteria

•Age: 18 - 39
•Infertility due to anovulation
•PCOS: At least two of the following diagnostic criteria of:
•Oligo/amenorrhoea
•Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence
•USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of \> 10 ml)
•No recent (within 6 months) treatment for induction of ovulation
•Normal semen analysis (WHO 1999)
•Proven patency of at least one Fallopian tube

Exclusion Criteria

•Inability to give informed consent
•Contraindication to letrozole or clomifene citrate
•Absence of any inclusion criteria

Arms & Interventions

Clomiphene citrate

Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg

Intervention: Clomifene citrate

Letrozole

Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg

Intervention: Letrozole

Outcomes

Primary Outcomes

Pregnancy rate

Time Frame: 14 moths

Secondary Outcomes

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(14 months)