Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women

May 23, 2011 updated by: University Magna Graecia

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

A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • "Pugliese" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy
  • PCOS

Exclusion Criteria:

  • Risk factors for pregnancy complications
  • Severe obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A1
metformin plus placebo
Drug: metformin plus placebo
metformin 850 mg cp, 2 cps daily
Experimental: Group A2
metformin plus folic acid
Drug: Metformin plus folic acid
metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily
Active Comparator: Group A3
placebo plus folic acid
Drug: placebo plus folic acid
Placebo 1 cp daily plus folic acid 0.4 mg daily
Placebo Comparator: Group A4
placebo cp, 2 cps daily
Drug: placebo alone
placebo cp, 2 cps daily
No Intervention: Group B
observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trophoblastic invasion.
Time Frame: two weeks
Istologic evaluation of trophoblastic ivasion,
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doppler velocimetry measurements of the uterine artery.
Time Frame: two weeks
Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Investigators

  • Study Chair: Fulvio Zullo, MD, Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

May 24, 2011

Last Update Submitted That Met QC Criteria

May 23, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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