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

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ClinicalTrials.gov Identifier: NCT01208740
Recruitment Status : Terminated (Concerns about safety at the first interim analysis)
First Posted : September 24, 2010
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:
University Magna Graecia

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.


Condition or disease Intervention/treatment Phase
Infertility PCOS Prognosis for Poor Response Drug: Metformin Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metformin
Metformin pre-treatment and co-administration
Drug: Metformin
500 mg three times daily
Placebo Comparator: Placebo
Placebo pre-treatment and co-administration
Drug: Placebo
1 pill three times daily



Primary Outcome Measures :
  1. Rate of cancellation due to low ovarian response [ Time Frame: one month ]
    Number of cancelled cycles/total cycles


Secondary Outcome Measures :
  1. Stimulation length [ Time Frame: one month ]
  2. Gonadotropins dose [ Time Frame: one month ]
  3. Ovulation rate [ Time Frame: one month ]
  4. pregnancy rate [ Time Frame: one month ]
  5. Live-birth rate [ Time Frame: nine months ]
  6. Adverse effects [ Time Frame: one month ]


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Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCOS
  • Prognosis for poor response
  • Infertility

Exclusion Criteria:

  • Male factor infertility
  • Tubal infertility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208740


Locations
Italy
Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Obstetrics and Gynecology, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01208740     History of Changes
Other Study ID Numbers: 02/2010
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: May 2011

Keywords provided by University Magna Graecia:
Gonadotropins
infertility
IVF
metformin
PCOS
poor prognosis
poor responder

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs