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Completed

NCT Number: NCT02498522

Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome

The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).

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Key information

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

About this study

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility

  • The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS
  • Research question:

In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?

-Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age : 25 - 35.
  • Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )
  • At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.
  • Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.
  • Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.
  • Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.

Exclusion criteria

  • patients with other causes of infertility other than PCOS
  • contraindications to metformin : liver impairment , renal failure.
  • Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.

Treatment and study plan

metformin

Drug

83 patients will continue metformin until end of 1st trimester

Other names: cidophage

Primary outcomes

  1. Miscarriage Rate

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: MIP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2015
Registry last updated
May 19, 2016

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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