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
  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 Intervention Phase
Infertility
PCOS
Prognosis for Poor Response
Drug: Metformin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

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


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 ]

Enrollment: 88
Study Start Date: January 2009
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCOS
  • Prognosis for poor response
  • Infertility

Exclusion Criteria:

  • Male factor infertility
  • Tubal infertility
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University Magna Graecia

Additional 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
Study First Received: May 24, 2010
Last Updated: May 23, 2011
Health Authority: Italy: The Italian Medicines Agency

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

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014