Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization | RxWiki

Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Infertility PCOS Prognosis for Poor Response
Intervention	Drug: Metformin Drug: Placebo
Phase	Phase 4
Sponsor	University Magna Graecia
Responsible Party	University Magna Graecia
ClinicalTrials.gov Identifier	NCT01208740
First Received	May 24, 2010
Last Updated	May 23, 2011
Last verified	May 2011

Tracking Information[ + expand ][ + ]

First Received Date	May 24, 2010
Last Updated Date	May 23, 2011
Start Date	January 2009
Estimated Primary Completion Date	March 2011
Current Primary Outcome Measures	Rate of cancellation due to low ovarian response [Time Frame: one month] [Designated as safety issue: No]Number of cancelled cycles/total cycles
Current Secondary Outcome Measures	Stimulation length [Time Frame: one month] [Designated as safety issue: No] Gonadotropins dose [Time Frame: one month] [Designated as safety issue: No] Ovulation rate [Time Frame: one month] [Designated as safety issue: No] pregnancy rate [Time Frame: one month] [Designated as safety issue: No] Live-birth rate [Time Frame: nine months] [Designated as safety issue: No] Adverse effects [Time Frame: one month] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization
Official Title	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.
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Infertility PCOS Prognosis for Poor Response
Intervention	Drug: Metformin 500 mg three times daily Drug: Placebo 1 pill three times daily
Study Arm (s)	Experimental: Metformin Metformin pre-treatment and co-administration Placebo Comparator: Placebo Placebo pre-treatment and co-administration

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	88
Estimated Completion Date	March 2011
Estimated Primary Completion Date	October 2010
Eligibility Criteria	Inclusion Criteria: - PCOS - Prognosis for poor response - Infertility Exclusion Criteria: - Male factor infertility - Tubal infertility
Gender	Female
Ages	35 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Italy

Administrative Information[ + expand ][ + ]

NCT Number	NCT01208740
Other Study ID Numbers	02/2010
Has Data Monitoring Committee	Yes
Information Provided By	University Magna Graecia
Study Sponsor	University Magna Graecia
Collaborators	Not Provided
Investigators	Study Chair: Fulvio Zullo, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of CatanzaroPrincipal Investigator: Stefano Palomba, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Verification Date	May 2011

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