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A Comparison Study of a Novel Stimulation Protocol With Metformin in Step-down Regimen and the Conventional Low Dose Step-up Protocol in Patients With Polycystic Ovary Syndrome Undergoing in Vitro Fertilization


Phase 4
18 Years
35 Years
Open (Enrolling)
Female
Infertility, PCOS

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Trial Information

A Comparison Study of a Novel Stimulation Protocol With Metformin in Step-down Regimen and the Conventional Low Dose Step-up Protocol in Patients With Polycystic Ovary Syndrome Undergoing in Vitro Fertilization


Inclusion Criteria:



- PCOS

- Infertility

- High responders

Exclusion Criteria:

- Poor responders

- Major medical conditions

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

OHSS rate

Outcome Description:

Ovarian hyperstimulation syndrome

Outcome Time Frame:

one month

Safety Issue:

Yes

Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Italy: The Italian Medicines Agency

Study ID:

09/2011

NCT ID:

NCT01438190

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Infertility
  • PCOS
  • Infertility
  • Polycystic Ovary Syndrome

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