NCT01693289

Brief Summary

the study compare the hormonal-metabolic and reproductive outcome between combined metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

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, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

5 months

First QC Date

September 23, 2012

Last Update Submit

September 25, 2012

Conditions

Focus of Study

Keywords

Metforminletrozoleovarian drillingclomiphene resistancepolycystic ovary.

Outcome Measures

Primary Outcomes (1)

  • hormonal and metabolic changes

    6 months

Secondary Outcomes (1)

  • reproductive outcome

    6months

Study Arms (2)

Metformin plus letrozole

EXPERIMENTAL

metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle

Drug: metformin plus letrozole

ovarian drilling

EXPERIMENTAL

bilateral diathermy ovarian drilling, four drills each ovary

Procedure: ovarian drilling

Interventions

metformin plus letrozoleDRUG
Also known as: cidophage plus fumara
Metformin plus letrozole
ovarian drillingPROCEDURE
Also known as: ovarian dithermy drilling
ovarian drilling

Eligibility Criteria

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

You may qualify if:

  • polycystic ovary syndrome
  • infertility
  • clomiphene citrate resistance

You may not qualify if:

  • women with other causes of infertility as male factor or tubal factor, those with endocrine disorders as thyroid dysfunction and hyperprolactinemia women who received hormonal treatment or ovulation induction drugs 3 months prior to the study
  • pregnancy during follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminLetrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsNitrilesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
obstetrics and gynecology department

Study Record Dates

First Submitted

September 23, 2012

First Posted

September 26, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

EG(1)