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

Phase 4

Terminated

• Conditions: Infertility; PCOS; Prognosis for Poor Response
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT01208740
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-24
• Primary Completion: 2010-10
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-23
• Last Update Posted: 2011-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• PCOS
• Prognosis for poor response
• Infertility

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Exclusion Criteria

• Male factor infertility
• Tubal infertility

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo pre-treatment and co-administration
Metformin	Metformin	Metformin pre-treatment and co-administration

Primary Outcome Measures

Name	Time	Method
Rate of cancellation due to low ovarian response	one month	Number of cancelled cycles/total cycles

Secondary Outcome Measures

Name	Time	Method
Stimulation length	one month
Gonadotropins dose	one month
Ovulation rate	one month
pregnancy rate	one month
Live-birth rate	nine months
Adverse effects	one month

Trial Locations

Locations (1)

Pugliese" Hospital; 🇮🇹 Catanzaro, Italy