Letrozole Versus Clomifene Citrate for Ovulation Induction

University of Nottingham159 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

159

Conditions

Infertility Polycystic Ovarian Syndrome

Interventions

LetrozoleDRUG

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

Clomifene citrateDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Derby Hospital

Derby, Derbyshire, United Kingdom

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

Time frame: 14 months

Data from ClinicalTrials.gov

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