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

University Magna Graecia

Status and phase: Terminated; Phase 4

Conditions: PCOS; Infertility; Prognosis for Poor Response

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01208740

02/2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: Female

Ages: 35 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PCOS
• Prognosis for poor response
• Infertility

Exclusion criteria

• Male factor infertility
• Tubal infertility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

Metformin pre-treatment and co-administration

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo pre-treatment and co-administration

Treatment:

Drug: Placebo