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
Overview[ - collapse ][ - ]
| 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 | Focus of Study |
| Intervention | Drug: metformin plus letrozole Procedure: ovarian drilling |
| Phase | Phase 1 |
| Sponsor | Zagazig University |
| Responsible Party | Zagazig University |
| ClinicalTrials.gov Identifier | NCT01693289 |
| First Received | September 23, 2012 |
| Last Updated | September 25, 2012 |
| Last verified | September 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 23, 2012 |
|---|---|
| Last Updated Date | September 25, 2012 |
| Start Date | January 2012 |
| Estimated Primary Completion Date | July 2012 |
| Current Primary Outcome Measures | hormonal and metabolic changes [Time Frame: 6 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | reproductive outcome [Time Frame: 6months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
|---|---|
| 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 |
| 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Focus of Study |
| Intervention | Drug: metformin plus letrozole Other Names: cidophage plus fumaraProcedure: ovarian drilling Other Names: ovarian dithermy drilling |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 146 |
| Estimated Completion Date | July 2012 |
| Estimated Primary Completion Date | June 2012 |
| Eligibility 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Egypt |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01693289 |
|---|---|
| Other Study ID Numbers | elsharkwy t |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Zagazig University |
| Study Sponsor | Zagazig University |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | September 2012 |
Locations[ + expand ][ + ]
| Zagazig University | Zagazig, Egypt |
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