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Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome


Phase 4
18 Years
38 Years
Not Enrolling
Female
Pregnancy, Polycystic Ovary Syndrome

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Trial Information

Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome


PCOS (cases) and non-PCOS (controls) pregnant women were enrolled. Cases will be randomized
in four treatment groups: metformin plus placebo (group A1), metformin plus folic acid
(group A2), placebo plus folic acid (group A3), placebo alone (group A4). Controls will not
received any treatment (group B). Clinical and biochemical assessment (including serum
markers of implantation), Doppler velocimetry of the uterine arteries, and trophoblastic
invasion at histological and immunohistochemical evaluation.

Changes in clinical and biochemical data under treatment, pattern of Doppler velocimetry at
the uterine arteries, and trophoblastic invasion were evaluated.


Inclusion Criteria:



- Pregnancy

- PCOS

Exclusion Criteria:

- Risk factors for pregnancy complications

- Severe obesity

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: Prevention

Outcome Measure:

Trophoblastic invasion.

Outcome Description:

Istologic evaluation of trophoblastic ivasion,

Outcome Time Frame:

two weeks

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:

01/2010

NCT ID:

NCT01115140

Start Date:

March 2010

Completion Date:

May 2011

Related Keywords:

  • Pregnancy
  • Polycystic Ovary Syndrome
  • Folate
  • Metformin
  • PCOS
  • Pregnancy
  • Trophoblastic invasion
  • Uterine artery velocimetry
  • Polycystic Ovary Syndrome

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