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

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. Identifier: NCT01693289
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
Information provided by (Responsible Party):
IBRAHIM ABD ELGAFOR, Zagazig University

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

Study Type : Interventional  (Clinical Trial)
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 : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: cidophage plus fumara
Experimental: ovarian drilling
bilateral diathermy ovarian drilling, four drills each ovary
Procedure: ovarian drilling
Other Name: ovarian dithermy drilling

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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

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 identifier (NCT number): NCT01693289

Zagazig University
Zagazig, Egypt
Sponsors and Collaborators
Zagazig University

Responsible Party: IBRAHIM ABD ELGAFOR, obstetrics and gynecology department, Zagazig University Identifier: NCT01693289     History of Changes
Other Study ID Numbers: elsharkwy t
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
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