Skip to main content
OpenTrials
Completed

NCT Number: NCT00478504

Letrozole Versus Clomifene Citrate for Ovulation Induction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Adnexal Diseases Anovulation Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovarian Syndrome Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 - 39
  • BMI < 36
  • Infertility due to anovulation
  • PCOS: At least two of the following diagnostic criteria of:
  • Oligo/amenorrhoea
  • Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence
  • USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml)
  • No recent (within 6 months) treatment for induction of ovulation
  • Normal semen analysis (WHO 1999)
  • Proven patency of at least one Fallopian tube

Exclusion criteria

  • Inability to give informed consent
  • Contraindication to letrozole or clomifene citrate
  • Absence of any inclusion criteria

Treatment and study plan

letrozole

Drug

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 citrate

Drug

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 outcomes

  1. Pregnancy rate

    Time frame: 14 moths

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

Registry information

Official study title

Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
May 24, 2007
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.