Double blind crossover randomised controlled trial comparing letrozole versus clomifene citrate for ovulation induction in women with polycystic ovarian syndrome

Conditions: Infertility due to polycycstic ovarian syndrome
MedDRA version: 8.1Level: LLTClassification code 10021935Term: Infertility, female, associated with anovulation

Registration Number: EUCTR2006-006514-15-GB

Lead Sponsor: The University of Nottingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1. Women aged 18 - 39

2. BMI < 35

3. Infertility due to anovulation

4. Diagnostic criteria: at least 2 of the following criteria of PCOS have to be fulfilled:
a) clinical: oligo/amenorrhoea
b) hyperandrogenenaemia: biochemical (testosterone >2.5 nmol/l or free androgen index (FAI) >5) or clinical (acne/hirsutism) evidence
c) USS evidence of PCO (either >12 follicles measuring 2-9mm in diameter, or an ovarian volume of 10ml)

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Inability to give informed consent

2. Contraindication to letrozole or cloifene citrate

3. The absence of any inclusion criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates than treatment with the current standard agent, clomifene citrate.;Secondary Objective: The secondary aims are:<br><br>1. To test the hypothesis that letrozole will produce fewer multiple pregnancies than treatment with clomifene citrate.<br><br>2. To test the hypothesis that letrozole will produce higher live birth rates than treatment with clomifene citrate.<br><br>3. The crossover design of the trial will help to test the efficacy of one drug in women who are resistant to the other.;Primary end point(s): The pregnancy rate after the first treatment and by the end of the crossover study.<br><br>

Secondary Outcome Measures