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

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01115140
First received: May 3, 2010
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pregnancy
Polycystic Ovary Syndrome
 Drug: metformin plus placebo
Drug: Metformin plus folic acid
Drug: placebo plus folic acid
Drug: placebo alone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Trophoblastic invasion. [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Istologic evaluation of trophoblastic ivasion,


Secondary Outcome Measures:
  • Doppler velocimetry measurements of the uterine artery. [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.


Enrollment: 50
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnancy
  • PCOS

Exclusion Criteria:

  • Risk factors for pregnancy complications
  • Severe obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115140

Locations
Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Study Chair: Fulvio Zullo, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Principal Investigator: Stefano Palomba, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
  More Information

No publications provided

Responsible Party: Department of Obstetrics and Gynecology, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01115140     History of Changes
Other Study ID Numbers: 01/2010
Study First Received: May 3, 2010
Last Updated: May 23, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:
Folate
Metformin
PCOS
 Pregnancy
Trophoblastic invasion
Uterine artery velocimetry

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
 Hematinics
Metformin
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses
Hypoglycemic Agents

ClinicalTrials.gov processed this record on June 18, 2013