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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115140
• Other study ID #: 01/2010
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2010
• Last updated: May 23, 2011
• Start date: March 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• Pregnancy

• PCOS

Exclusion Criteria:

• Risk factors for pregnancy complications

• Severe obesity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Pregnancy
• Syndrome

Intervention

Drug:
• metformin plus placebo
metformin 850 mg cp, 2 cps daily
• Metformin plus folic acid
metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily
• placebo plus folic acid
Placebo 1 cp daily plus folic acid 0.4 mg daily
• placebo alone
placebo cp, 2 cps daily

Locations

Country	Name	City	State
Italy	"Pugliese" Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trophoblastic invasion.	Istologic evaluation of trophoblastic ivasion,	two weeks	No
Secondary	Doppler velocimetry measurements of the uterine artery.	Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.	two weeks	No