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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

NCT ID: NCT01693289

Last Updated: 2012-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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Conditions

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Focus of Study

Keywords

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Metformin letrozole ovarian drilling clomiphene resistance polycystic ovary.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin plus letrozole

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

Group Type EXPERIMENTAL

metformin plus letrozole

Intervention Type DRUG

ovarian drilling

bilateral diathermy ovarian drilling, four drills each ovary

Group Type EXPERIMENTAL

ovarian drilling

Intervention Type PROCEDURE

Interventions

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metformin plus letrozole

Intervention Type DRUG

ovarian drilling

Intervention Type PROCEDURE

Other Intervention Names

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cidophage plus fumara ovarian dithermy drilling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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IBRAHIM ABD ELGAFOR

obstetrics and gynecology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig University

Zagazig, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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elsharkwy t

Identifier Type: -

Identifier Source: org_study_id