Letrozole Versus Clomifene Citrate for Ovulation Induction

University of Nottingham

Status and phase: Completed; Phase 4

Conditions: Infertility; Polycystic Ovarian Syndrome

Treatments: Drug: Clomifene citrate; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT00478504

EudraCT No: 2006-006514-15

RD-5103-015-06

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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159 participants in 2 patient groups

Clomiphene citrate

Active Comparator group

Description:

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

Treatment:

Drug: Clomifene citrate

Letrozole

Active Comparator group

Description:

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

Treatment:

Drug: Letrozole