Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization
This study has been terminated.
(Concerns about safety at the first interim analysis)
Sponsor:
University Magna Graecia
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01208740
First received: May 24, 2010
Last updated: May 23, 2011
Last verified: May 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 24, 2010 | ||||||||
| Last Updated Date | May 23, 2011 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Rate of cancellation due to low ovarian response [ Time Frame: one month ] [ Designated as safety issue: No ] Number of cancelled cycles/total cycles |
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| Original Primary Outcome Measures ICMJE |
Cancellation rate [ Time Frame: one month ] [ Designated as safety issue: No ] Number of cancelled cycles/total cycles |
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| Change History | Complete list of historical versions of study NCT01208740 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization | ||||||||
| Official Title ICMJE | Effects of Metformin on the Ovarian Response to Gonadotropins for in Vitro Fertilization Treatment in Patients With Polycystic Ovary Syndrome and Predictors of Poor Ovarian Response | ||||||||
| Brief Summary | Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking. On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles. |
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| Detailed Description | Primary infertile patients with PCOS older than 35 years and/or with a basal follicle-stimulating hormone (FSH) level higher than 10 IU/L who were scheduled for IVF cycles were enrolled in the study protocol. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Palomba S, Falbo A, Di Cello A, Cappiello F, Tolino A, Zullo F. Does metformin affect the ovarian response to gonadotropins for in vitro fertilization treatment in patients with polycystic ovary syndrome and reduced ovarian reserve? A randomized controlled trial. Fertil Steril. 2011 Nov;96(5):1128-33. Epub 2011 Sep 13. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 88 | ||||||||
| Completion Date | March 2011 | ||||||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 35 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Italy | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01208740 | ||||||||
| Other Study ID Numbers ICMJE | 02/2010 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Department of Obstetrics and Gynecology, University Magna Graecia | ||||||||
| Study Sponsor ICMJE | University Magna Graecia | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Magna Graecia | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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