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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin arm<br>83 patients will continue metformin until end of 1st trimester (14 weeks gestation) | Drug: Metformin<br>* 83 patients will continue metformin until end of 1st trimester<br>* Other names: cidophage;|
| Placebo Comparator: control arm<br>83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) | Drug: Metformin<br>* 83 patients will continue metformin until end of 1st trimester<br>* Other names: cidophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage Rate |  | 6 months |