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

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

Overview[ - collapse ][ - ]

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	Pregnancy Polycystic Ovary Syndrome
Intervention	Drug: metformin plus placebo Drug: Metformin plus folic acid Drug: placebo plus folic acid Drug: placebo alone
Phase	Phase 4
Sponsor	University Magna Graecia
Responsible Party	University Magna Graecia
ClinicalTrials.gov Identifier	NCT01115140
First Received	May 3, 2010
Last Updated	May 23, 2011
Last verified	May 2011

Tracking Information[ + expand ][ + ]

First Received Date	May 3, 2010
Last Updated Date	May 23, 2011
Start Date	March 2010
Estimated Primary Completion Date	May 2011
Current Primary Outcome Measures	Trophoblastic invasion. [Time Frame: two weeks] [Designated as safety issue: No]Istologic evaluation of trophoblastic ivasion,
Current 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.

Descriptive Information[ + expand ][ + ]

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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Condition	Pregnancy Polycystic Ovary Syndrome
Intervention	Drug: metformin plus placebo metformin 850 mg cp, 2 cps daily Drug: Metformin plus folic acid metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily Drug: placebo plus folic acid Placebo 1 cp daily plus folic acid 0.4 mg daily Drug: placebo alone placebo cp, 2 cps daily
Study Arm (s)	Active Comparator: Group A1 metformin plus placebo Experimental: Group A2 metformin plus folic acid Active Comparator: Group A3 placebo plus folic acid Placebo Comparator: Group A4 placebo cp, 2 cps daily No Intervention: Group B observation

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	50
Estimated Completion Date	May 2011
Estimated Primary Completion Date	May 2011
Eligibility Criteria	Inclusion Criteria: - Pregnancy - PCOS Exclusion Criteria: - Risk factors for pregnancy complications - Severe obesity
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Italy

Administrative Information[ + expand ][ + ]

NCT Number	NCT01115140
Other Study ID Numbers	01/2010
Has Data Monitoring Committee	Yes
Information Provided By	University Magna Graecia
Study Sponsor	University Magna Graecia
Collaborators	Not Provided
Investigators	Study Chair: Fulvio Zullo, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of CatanzaroPrincipal Investigator: Stefano Palomba, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Verification Date	May 2011

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