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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:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01208740
First received: May 24, 2010
Last updated: May 23, 2011
Last verified: May 2011

May 24, 2010
May 23, 2011
January 2009
October 2010   (final data collection date for primary outcome measure)
Rate of cancellation due to low ovarian response [ Time Frame: one month ] [ Designated as safety issue: No ]
Number of cancelled cycles/total cycles
Cancellation rate [ Time Frame: one month ] [ Designated as safety issue: No ]
Number of cancelled cycles/total cycles
Complete list of historical versions of study NCT01208740 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Infertility
  • PCOS
  • Prognosis for Poor Response
  • Drug: Metformin
    500 mg three times daily
  • Drug: Placebo
    1 pill three times daily
  • Experimental: Metformin
    Metformin pre-treatment and co-administration
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo
    Placebo pre-treatment and co-administration
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
88
March 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • PCOS
  • Prognosis for poor response
  • Infertility

Exclusion Criteria:

  • Male factor infertility
  • Tubal infertility
Female
35 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01208740
02/2010
Yes
Department of Obstetrics and Gynecology, University Magna Graecia
University Magna Graecia
Not Provided
Study Chair: Fulvio Zullo, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Principal Investigator: Stefano Palomba, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
University Magna Graecia
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP