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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

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT01693289
Collaborator
(none)
146
Enrollment
1
Location
2
Arms
6
Duration (Months)
24.4
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: metformin plus letrozole
  • Procedure: ovarian drilling
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. hormonal and metabolic changes [6 months]

    Secondary Outcome Measures

    1. reproductive outcome [6months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zagazig University Zagazig Egypt

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IBRAHIM ABD ELGAFOR, obstetrics and gynecology department, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT01693289
    Other Study ID Numbers:
    • elsharkwy t
    First Posted:
    Sep 26, 2012
    Last Update Posted:
    Sep 26, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by IBRAHIM ABD ELGAFOR, obstetrics and gynecology department, Zagazig University
    Metformin
    letrozole
    ovarian drilling
    clomiphene resistance
    polycystic ovary.
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Metformin
    Letrozole

    Study Results

    No Results Posted as of Sep 26, 2012