NCT00478504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

7.1 years

First QC Date

May 23, 2007

Last Update Submit

October 26, 2016

Conditions

InfertilityPolycystic Ovarian Syndrome

Keywords

anovulationovulation induction,polycystic ovarian syndromeclomifene citrateletrozole

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    14 moths

Secondary Outcomes (1)

  • 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

Study Arms (2)

Clomiphene citrate

ACTIVE COMPARATOR

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

Drug: Clomifene citrate

Letrozole

ACTIVE COMPARATOR

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

Drug: Letrozole

Interventions

LetrozoleDRUG

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

Letrozole
Clomifene citrateDRUG

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

Clomiphene citrate

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to give informed consent
  • Contraindication to letrozole or clomifene citrate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28854590DERIVED

Related Links

MeSH Terms

Conditions

InfertilityPolycystic Ovary SyndromeAnovulation

Interventions

LetrozoleClomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Saad Amer, MD, MRCOG

    University of Nottingham and Derby Hospitals NHS foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

GB(1)