Letrozole Versus Clomifene Citrate for Ovulation Induction

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478504
• Other study ID #: RD-5103-015-06
• Secondary ID: EudraCT No: 2006
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2007
• Last updated: October 26, 2016
• Start date: May 2007
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Letrozole
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
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

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby	Derbyshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Derby Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate		14 moths	No
Secondary	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		14 months	No

External Links

•   Link
•   Lay summary of the trial
•   Patient information sheet