Trial Information
Phase 1 Study of Efficacy of Combined Metformin-letrozole in Comparison With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
hormonal and metabolic changes
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
Egypt:Zagazig University
Study ID:
elsharkwy t
NCT ID:
NCT01693289
Start Date:
January 2012
Completion Date:
July 2012
Related Keywords:
- Focus of Study
- Metformin
- letrozole
- ovarian drilling
- clomiphene resistance
- polycystic ovary.
- Polycystic Ovary Syndrome