NCT01679574

Brief Summary

The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not treated before with any ovulation induction agent

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

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

January 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

3 years

First QC Date

August 31, 2012

Last Update Submit

September 6, 2012

Conditions

Polycystic Ovary Syndrome

Keywords

PCO

Outcome Measures

Primary Outcomes (1)

  • ovulation rate

    Principally the ovulation rate as well as the number of growing and mature follicles and endometrial thickness (mm).

    3 years

Secondary Outcomes (1)

  • The occurrence of pregnancy and miscarriage

    3 years

Study Arms (2)

letrozole

EXPERIMENTAL

Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days

Drug: Letrozole

Metformin and clomiphene

ACTIVE COMPARATOR

.Drug: metformin (Cidophage®; CID,Cairo, Egypt) metformin 1500 daily for 3 months * Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation

Drug: ClomipheneDrug: Metformin

Interventions

LetrozoleDRUG

•Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days

Also known as: Femara; Novartis Pharma, Switzerland
letrozole
ClomipheneDRUG

•Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation

Also known as: clomid
Metformin and clomiphene
MetforminDRUG

•Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt) metformin HCl 1500 daily for 3 months

Also known as: Cidophage
Metformin and clomiphene

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants met the Rotterdam consensus criteria for the diagnosis of PCOS . .Primary infertility because of anovulation for at least 1 year.
  • Only fresh (not treated previously) cases were recruited. .The male partner of each participant was required to have a normal result on semen analysis (count\>20million/ml,motility\>40%and normal morphology \>30%).
  • Each woman was required to have patent tubes on hysterosalpingography or on a diagnostic laparoscopy.

You may not qualify if:

  • Age below 18 years or above 35 years , trial of ovulation induction prior to the stud ,BMI \>35 .
  • Presence of other causes of infertility; hyperprolactinemia (morning plasma prolactin concentration 30 ng/mL or more); any other endocrine, hepatic, or renal disorder; presence of an organic pelvic mass;
  • History of abdominal surgery that might have caused pelvic factor infertility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

LetrozoleClomipheneMetformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tarek al Hussaini, prof

    Assiut University

    STUDY CHAIR

  • Safowt Abd El Rady, Prof

    Assiut university hosiptal

    STUDY DIRECTOR

  • Mohamad S Abd Allah, Ass prof

    assiut university hosital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicple investigator

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 6, 2012

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations

EG(1)