Study to Compare Between Combimed Metformin-letrozole and Ovarian Drilling in Pcos With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome

September 25, 2012 updated by: IBRAHIM ABD ELGAFOR, Zagazig University

Phase 1 Study of Efficacy of Combined Metformin-letrozole in Comparison With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • polycystic ovary syndrome
  • infertility
  • clomiphene citrate resistance

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin plus letrozole
metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle
Drug: metformin plus letrozole
Other Names:
  • cidophage plus fumara
Experimental: ovarian drilling
bilateral diathermy ovarian drilling, four drills each ovary
Procedure: ovarian drilling
Other Names:
  • ovarian dithermy drilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hormonal and metabolic changes
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
reproductive outcome
Time Frame: 6months
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 23, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • elsharkwy t

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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