Back to resultsMetformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women
Primary Purpose
Pregnancy, Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
metformin plus placebo
Metformin plus folic acid
placebo plus folic acid
placebo alone
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Folate, Metformin, PCOS, Pregnancy, Trophoblastic invasion, Uterine artery velocimetry
Eligibility Criteria
Inclusion Criteria:
- Pregnancy
- PCOS
Exclusion Criteria:
- Risk factors for pregnancy complications
- Severe obesity
Sites / Locations
- "Pugliese" Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Group A1
Group A2
Group A3
Group A4
Group B
Arm Description
metformin plus placebo
metformin plus folic acid
placebo plus folic acid
placebo cp, 2 cps daily
observation
Outcomes
Primary Outcome Measures
Trophoblastic invasion.
Istologic evaluation of trophoblastic ivasion,
Secondary Outcome Measures
Doppler velocimetry measurements of the uterine artery.
Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01115140
Brief Title
Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women
Official Title
Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Magna Graecia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Polycystic Ovary Syndrome
Keywords
Folate, Metformin, PCOS, Pregnancy, Trophoblastic invasion, Uterine artery velocimetry
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A1
Arm Type
Active Comparator
Arm Description
metformin plus placebo
Arm Title
Group A2
Arm Type
Experimental
Arm Description
metformin plus folic acid
Arm Title
Group A3
Arm Type
Active Comparator
Arm Description
placebo plus folic acid
Arm Title
Group A4
Arm Type
Placebo Comparator
Arm Description
placebo cp, 2 cps daily
Arm Title
Group B
Arm Type
No Intervention
Arm Description
observation
Intervention Type
Drug
Intervention Name(s)
metformin plus placebo
Intervention Description
metformin 850 mg cp, 2 cps daily
Intervention Type
Drug
Intervention Name(s)
Metformin plus folic acid
Intervention Description
metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily
Intervention Type
Drug
Intervention Name(s)
placebo plus folic acid
Intervention Description
Placebo 1 cp daily plus folic acid 0.4 mg daily
Intervention Type
Drug
Intervention Name(s)
placebo alone
Intervention Description
placebo cp, 2 cps daily
Primary Outcome Measure Information:
Title
Trophoblastic invasion.
Description
Istologic evaluation of trophoblastic ivasion,
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Doppler velocimetry measurements of the uterine artery.
Description
Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.
Time Frame
two weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnancy
PCOS
Exclusion Criteria:
Risk factors for pregnancy complications
Severe obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Pugliese" Hospital
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women
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