NCT01208740

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: Female
• Age: 35 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility
• PCOS
• Prognosis for Poor Response

Interventions

Type	Name	Description
DRUG	Metformin	500 mg three times daily
DRUG	Placebo	1 pill three times daily

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2010-09-24
• Last updated: 2011-05-24

Locations

1 site across 1 country: Italy