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Completed

NCT Number: NCT01115140

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

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.

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Key information

Conditions

Pregnancy Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

"Pugliese" Hospital

Catanzaro, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnancy
  • PCOS

Exclusion criteria

  • Risk factors for pregnancy complications
  • Severe obesity

Treatment and study plan

Metformin plus Placebo

Drug

metformin 850 mg cp, 2 cps daily

Metformin plus folic acid

Drug

metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily

placebo plus folic acid

Drug

Placebo 1 cp daily plus folic acid 0.4 mg daily

placebo alone

Drug

placebo cp, 2 cps daily

Primary outcomes

  1. Trophoblastic invasion.

    Time frame: two weeks

    Istologic evaluation of trophoblastic ivasion,

Secondary outcomes

  1. Doppler velocimetry measurements of the uterine artery.

    Time frame: two weeks

    Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 4, 2010
Registry last updated
May 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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