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


Phase 4
18 Years
39 Years
Open (Enrolling)
Female
Infertility, Polycystic Ovarian Syndrome

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Pregnancy rate

Principal Investigator

Saad Amer, MD, MRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nottingham and Derby Hospitals NHS foundation Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

RD-5103-015-06

NCT ID:

NCT00478504

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Infertility
  • Polycystic Ovarian Syndrome
  • anovulation
  • ovulation induction,
  • polycystic ovarian syndrome
  • clomifene citrate
  • letrozole
  • Infertility
  • Polycystic Ovary Syndrome

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