Infertility due to polycycstic ovarian syndrome MedDRA version: 8.1 Level: LLT Classification code 10021935 Term: Infertility, female, associated with anovulation
Conditions
Interventions
Trade Name: Femara
Product Name: Letrozole
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Letrozole
Concentration unit: mg milligram(s)
Concentration number: 2.5-
Trade Name: Clomid
Pro
Sponsors
The University of Nottingham
Derby Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women aged 18 - 39 2. BMI 2.5 nmol/l or free androgen index (FAI) >5) or clinical (acne/hirsutism) evidence c) USS evidence of PCO (either >12 follicles measuring 2-9mm in diameter, or an ovarian volume of 10ml) 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent 2. Contraindication to letrozole or cloifene citrate 3. The absence of any inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates than treatment with the current standard agent, clomifene citrate.;Secondary Objective: The secondary aims are: 1. To test the hypothesis that letrozole will produce fewer multiple pregnancies than treatment with clomifene citrate. 2. To test the hypothesis that letrozole will produce higher live birth rates than treatment with clomifene citrate. 3. The crossover design of the trial will help to test the efficacy of one drug in women who are resistant to the other.;Primary end point(s): The pregnancy rate after the first treatment and by the end of the crossover study. | — |
Countries
United Kingdom
Outcome results
None listed