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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


Phase 4
35 Years
45 Years
Not Enrolling
Female
Infertility, PCOS, Prognosis for Poor Response

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Trial Information

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


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.


Inclusion Criteria:



- PCOS

- Prognosis for poor response

- Infertility

Exclusion Criteria:

- Male factor infertility

- Tubal infertility

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of cancellation due to low ovarian response

Outcome Description:

Number of cancelled cycles/total cycles

Outcome Time Frame:

one month

Safety Issue:

No

Principal Investigator

Fulvio Zullo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

Italy: The Italian Medicines Agency

Study ID:

02/2010

NCT ID:

NCT01208740

Start Date:

January 2009

Completion Date:

March 2011

Related Keywords:

  • Infertility
  • PCOS
  • Prognosis for Poor Response
  • Gonadotropins
  • infertility
  • IVF
  • metformin
  • PCOS
  • poor prognosis
  • poor responder
  • Infertility
  • Polycystic Ovary Syndrome

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