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

Primary Purpose

Infertility, PCOS, Prognosis for Poor Response

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Gonadotropins, infertility, IVF, metformin, PCOS, poor prognosis, poor responder

Eligibility Criteria

35 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • PCOS
  • Prognosis for poor response
  • Infertility

Exclusion Criteria:

  • Male factor infertility
  • Tubal infertility

Sites / Locations

  • Pugliese" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

Metformin pre-treatment and co-administration

Placebo pre-treatment and co-administration

Outcomes

Primary Outcome Measures

Rate of cancellation due to low ovarian response
Number of cancelled cycles/total cycles

Secondary Outcome Measures

Stimulation length
Gonadotropins dose
Ovulation rate
pregnancy rate
Live-birth rate
Adverse effects

Full Information

First Posted
May 24, 2010
Last Updated
May 23, 2011
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT01208740
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
Concerns about safety at the first interim analysis
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, PCOS, Prognosis for Poor Response
Keywords
Gonadotropins, infertility, IVF, metformin, PCOS, poor prognosis, poor responder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin pre-treatment and co-administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pre-treatment and co-administration
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
500 mg three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 pill three times daily
Primary Outcome Measure Information:
Title
Rate of cancellation due to low ovarian response
Description
Number of cancelled cycles/total cycles
Time Frame
one month
Secondary Outcome Measure Information:
Title
Stimulation length
Time Frame
one month
Title
Gonadotropins dose
Time Frame
one month
Title
Ovulation rate
Time Frame
one month
Title
pregnancy rate
Time Frame
one month
Title
Live-birth rate
Time Frame
nine months
Title
Adverse effects
Time Frame
one month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PCOS Prognosis for poor response Infertility Exclusion Criteria: Male factor infertility Tubal infertility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pugliese" Hospital
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21917254
Citation
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. doi: 10.1016/j.fertnstert.2011.08.020. Epub 2011 Sep 13.
Results Reference
derived

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

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