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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
Information provided by:
Derby Hospitals NHS Foundation Trust Identifier:
First received: May 23, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
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
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:

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

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00478504

Contact: Saad Amer, MD, MRCOG +44(1332)724612

United Kingdom
Derby City General Hospital Recruiting
Derby, Derbyshire, United Kingdom, DE22 3NE
Contact: Saad Amer, MD, MRCOG    +44(1332)724612   
Sponsors and Collaborators
Derby Hospitals NHS Foundation Trust
Principal Investigator: Saad Amer, MD, MRCOG University of Nottingham and Derby Hospitals NHS foundation Trust
  More Information 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:
ovulation induction,
polycystic ovarian syndrome
clomifene citrate

Additional relevant MeSH terms:
Ovarian Cysts
Polycystic Ovary Syndrome
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists processed this record on October 25, 2016