MedDataX Logo

Letrozole Versus Clomifene Citrate for Ovulation Induction

NCT ID: NCT00478504

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility Polycystic Ovarian Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

anovulation ovulation induction, polycystic ovarian syndrome clomifene citrate letrozole

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clomiphene 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

Group Type ACTIVE_COMPARATOR

Clomifene citrate

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Letrozole

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Saad Amer

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saad Amer, MD, MRCOG

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham and Derby Hospitals NHS foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Derby Hospital

Derby, Derbyshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28854590 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.derbyhospitals.nhs.uk/research/

Related Info

http://saadamer.com/clet-trial-for-pcos/

Lay summary of the trial

http://saadamer.com/docs/CLET_Patient_information_sheet.pdf

Patient information sheet

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT No: 2006-006514-15

Identifier Type: -

Identifier Source: secondary_id

RD-5103-015-06

Identifier Type: -

Identifier Source: org_study_id