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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693289
First Posted: September 26, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IBRAHIM ABD ELGAFOR, Zagazig University
  Purpose
the study compare the hormonal-metabolic and reproductive outcome between combined metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic syndrome

Condition Intervention Phase
Focus of Study Drug: metformin plus letrozole Procedure: ovarian drilling Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by IBRAHIM ABD ELGAFOR, Zagazig University:

Primary Outcome Measures:
  • hormonal and metabolic changes [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • reproductive outcome [ Time Frame: 6months ]

Enrollment: 146
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: cidophage plus fumara
Experimental: ovarian drilling
bilateral diathermy ovarian drilling, four drills each ovary
Procedure: ovarian drilling
Other Name: ovarian dithermy drilling

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693289


Locations
Egypt
Zagazig University
Zagazig, Egypt
Sponsors and Collaborators
Zagazig University
  More Information

Responsible Party: IBRAHIM ABD ELGAFOR, obstetrics and gynecology department, Zagazig University
ClinicalTrials.gov Identifier: NCT01693289     History of Changes
Other Study ID Numbers: elsharkwy t
First Submitted: September 23, 2012
First Posted: September 26, 2012
Last Update Posted: October 12, 2017
Last Verified: September 2012

Keywords provided by IBRAHIM ABD ELGAFOR, Zagazig University:
Metformin
letrozole
ovarian drilling
clomiphene resistance
polycystic ovary.

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Letrozole
Clomiphene
Enclomiphene
Zuclomiphene
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators