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:
Information provided by (Responsible Party):
IBRAHIM ABD ELGAFOR, Zagazig University
ClinicalTrials.gov Identifier:
NCT01693289
First received: September 23, 2012
Last updated: September 25, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Zagazig University:

Primary Outcome Measures:
  • hormonal and metabolic changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reproductive outcome [ Time Frame: 6months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693289

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

No publications provided

Responsible Party: IBRAHIM ABD ELGAFOR, obstetrics and gynecology department, Zagazig University
ClinicalTrials.gov Identifier: NCT01693289     History of Changes
Other Study ID Numbers: elsharkwy t
Study First Received: September 23, 2012
Last Updated: September 25, 2012
Health Authority: Egypt:Zagazig University

Keywords provided by 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
Clomiphene
Letrozole
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014