Letrozole Versus Clomifene Citrate for Ovulation Induction

Phase 4

Completed

• Conditions: Infertility; Polycystic Ovarian Syndrome
• Interventions: Drug: Letrozole; Drug: Clomifene citrate

• Registration Number: NCT00478504
• Lead Sponsor: University of Nottingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Letrozole	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
Clomiphene citrate	Clomifene 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

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	14 moths

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Derby Hospital; 🇬🇧 Derby, Derbyshire, United Kingdom