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Letrozole Versus Clomifene Citrate for Ovulation Induction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Derby Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Derby Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00478504
First received: May 23, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Infertility
Polycystic Ovarian Syndrome
 Drug: Letrozole
Drug: Clomifene citrate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double Blind Cross-Over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Derby Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Pregnancy rate

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 212
Study Start Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478504

Contacts
Contact: Saad Amer, MD, MRCOG +44(1332)724612 saad.amer@nottingham.ac.uk

Locations
United Kingdom
Derby City General Hospital Recruiting
Derby, Derbyshire, United Kingdom, DE22 3NE
Contact: Saad Amer, MD, MRCOG     +44(1332)724612     saad.amer@nottingham.ac.uk    
Sponsors and Collaborators
Derby Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Saad Amer, MD, MRCOG University of Nottingham and Derby Hospitals NHS foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00478504     History of Changes
Other Study ID Numbers: RD-5103-015-06, EudraCT No: 2006-006514-15
Study First Received: May 23, 2007
Last Updated: May 23, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Derby Hospitals NHS Foundation Trust:
anovulation
ovulation induction,
polycystic ovarian syndrome
clomifene citrate
letrozole

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Letrozole
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013