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

NCT ID: NCT01208740

Last Updated: 2011-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Infertility PCOS Prognosis for Poor Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metformin

Metformin pre-treatment and co-administration

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

500 mg three times daily

Placebo

Placebo pre-treatment and co-administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 pill three times daily

Interventions

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Metformin

500 mg three times daily

Intervention Type DRUG

Placebo

1 pill three times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PCOS
* Prognosis for poor response
* Infertility

Exclusion Criteria

* Male factor infertility
* Tubal infertility
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Responsible Party

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University Magna Graecia

Principal Investigators

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Fulvio Zullo, MD

Role: STUDY_CHAIR

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Stefano Palomba, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Locations

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Pugliese" Hospital

Catanzaro, Italy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 21917254 (View on PubMed)

Other Identifiers

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02/2010

Identifier Type: -

Identifier Source: org_study_id

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