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Metformin Addition to Gonadotropins Ovarian Stimulation in High Responder Patients With PCOS Undergoing In-vitro Fertilization


Phase 4
18 Years
35 Years
Not Enrolling
Female
Infertility, Polycystic Ovary Syndrome (PCOS)

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Trial Information

Metformin Addition to Gonadotropins Ovarian Stimulation in High Responder Patients With PCOS Undergoing In-vitro Fertilization


Infertile young non-obese insulin-resistant patients with PCOS who had a background of the
first IVF treatment cycle cancelled because of high risk for OHSS will be enrolled and
randomized in two treatment arms.

In their second IVF attempt, the experimental group will receive metformin (500 mg, 3 times
daily) pre-treatment for two weeks and co-administration during gonadotropins ovarian
stimulation; the control group will be treated with placebo (2 cps daily) pre-treatment and
co-administration by using the same schedule of the experimental group. In all patients,
ovarian stimulation will be carried out with a personalized step-down gonadotropin in
association with a minidose flare-up GnRH agonist protocol.


Inclusion Criteria:



- History of one previous cancelled cycle for high-risk of OHSS, or history of
moderate/severe OHSS during their previous IVF cycle

- Infertility

- Polycystic ovary syndrome (PCOS)

- insulin resistance

- hyperandrogenism

Exclusion Criteria:

- BMI>30 kg/m2

- age >35 years

- FSH>9UI/L

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of OHSS

Outcome Time Frame:

one month

Safety Issue:

Yes

Principal Investigator

Stefano Palomba

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Magna Graecia

Authority:

Italy: The Italian Medicines Agency

Study ID:

04/2010

NCT ID:

NCT01233206

Start Date:

May 2009

Completion Date:

January 2011

Related Keywords:

  • Infertility
  • Polycystic Ovary Syndrome (PCOS)
  • PCOS
  • Polycystic ovary syndrome
  • Cancelled cycles
  • OHSS
  • Infertility
  • Infertility
  • Polycystic Ovary Syndrome

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