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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01208740
• Other study ID #: 02/2010
• Status: Terminated
• Phase: Phase 4
• First received: May 24, 2010
• Last updated: May 23, 2011
• Start date: January 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: March 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• PCOS

• Prognosis for poor response

• Infertility

Exclusion Criteria:

• Male factor infertility

• Tubal infertility

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• PCOS
• Prognosis for Poor Response

Intervention

Drug:
• Metformin
500 mg three times daily
• Placebo
1 pill three times daily

Locations

Country	Name	City	State
Italy	Pugliese" Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cancellation due to low ovarian response	Number of cancelled cycles/total cycles	one month	No
Secondary	Stimulation length		one month	No
Secondary	Gonadotropins dose		one month	No
Secondary	Ovulation rate		one month	No
Secondary	pregnancy rate		one month	No
Secondary	Live-birth rate		nine months	No
Secondary	Adverse effects		one month	Yes