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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

Primary Purpose

Focus of Study

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
metformin plus letrozole
ovarian drilling
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focus of Study focused on measuring Metformin, letrozole, ovarian drilling, clomiphene resistance, polycystic ovary.

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zagazig University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Metformin plus letrozole

ovarian drilling

Arm Description

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

bilateral diathermy ovarian drilling, four drills each ovary

Outcomes

Primary Outcome Measures

hormonal and metabolic changes

Secondary Outcome Measures

reproductive outcome

Full Information

First Posted
September 23, 2012
Last Updated
September 25, 2012
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT01693289
Brief Title
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
Official Title
Phase 1 Study of Efficacy of Combined Metformin-letrozole in Comparison With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focus of Study
Keywords
Metformin, letrozole, ovarian drilling, clomiphene resistance, polycystic ovary.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin plus letrozole
Arm Type
Experimental
Arm Description
metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle
Arm Title
ovarian drilling
Arm Type
Experimental
Arm Description
bilateral diathermy ovarian drilling, four drills each ovary
Intervention Type
Drug
Intervention Name(s)
metformin plus letrozole
Other Intervention Name(s)
cidophage plus fumara
Intervention Type
Procedure
Intervention Name(s)
ovarian drilling
Other Intervention Name(s)
ovarian dithermy drilling
Primary Outcome Measure Information:
Title
hormonal and metabolic changes
Time Frame
6 months
Secondary Outcome Measure Information:
Title
reproductive outcome
Time Frame
6months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Zagazig University
City
Zagazig
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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