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

Sponsor

University Magna Graecia (Other)

Overall Status

Completed

CT.gov ID

NCT01115140

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Trophoblastic invasion. [two weeks]
Istologic evaluation of trophoblastic ivasion,

Secondary Outcome Measures

Doppler velocimetry measurements of the uterine artery. [two weeks]
Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pregnancy
PCOS

Exclusion Criteria:

Risk factors for pregnancy complications
Severe obesity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"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