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Letrozole Versus Clomifene Citrate for Ovulation Induction

Primary Purpose

Infertility, Polycystic Ovarian Syndrome

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Letrozole
Clomifene citrate
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring anovulation, ovulation induction,, polycystic ovarian syndrome, clomifene citrate, letrozole

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Derby Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clomiphene citrate

Letrozole

Arm Description

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

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

Outcomes

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

Full Information

First Posted
May 23, 2007
Last Updated
October 26, 2016
Sponsor
University of Nottingham
Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00478504
Brief Title
Letrozole Versus Clomifene Citrate for Ovulation Induction
Official Title
Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nottingham
Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Polycystic Ovarian Syndrome
Keywords
anovulation, ovulation induction,, polycystic ovarian syndrome, clomifene citrate, letrozole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clomiphene citrate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Letrozole
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Clomifene citrate
Intervention Description
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
Primary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
14 moths
Secondary Outcome Measure Information:
Title
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
Time Frame
14 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18 - 39 BMI < 36 Infertility due to anovulation PCOS: At least two of the following diagnostic criteria of: Oligo/amenorrhoea Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml) No recent (within 6 months) treatment for induction of ovulation Normal semen analysis (WHO 1999) Proven patency of at least one Fallopian tube Exclusion Criteria: Inability to give informed consent Contraindication to letrozole or clomifene citrate Absence of any inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Amer, MD, MRCOG
Organizational Affiliation
University of Nottingham and Derby Hospitals NHS foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Derby Hospital
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3NE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28854590
Citation
Amer SA, Smith J, Mahran A, Fox P, Fakis A. Double-blind randomized controlled trial of letrozole versus clomiphene citrate in subfertile women with polycystic ovarian syndrome. Hum Reprod. 2017 Aug 1;32(8):1631-1638. doi: 10.1093/humrep/dex227.
Results Reference
derived
Links:
URL
http://www.derbyhospitals.nhs.uk/research/
Description
Related Info
URL
http://saadamer.com/clet-trial-for-pcos/
Description
Lay summary of the trial
URL
http://saadamer.com/docs/CLET_Patient_information_sheet.pdf
Description
Patient information sheet

Learn more about this trial

Letrozole Versus Clomifene Citrate for Ovulation Induction

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