Letrozole Versus Clomifene Citrate for Ovulation Induction

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nottingham
• Collaborators: Derby Hospitals NHS Foundation Trust; University Hospitals of Derby and Burton NHS Foundation Trust
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Letrozole; Zuclomiphene

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