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

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ClinicalTrials.gov Identifier: NCT02498522
Recruitment Status : Completed
First Posted : July 15, 2015
Results First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Islam Dabbous, Ain Shams University

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Early Phase 1

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
Study Start Date : August 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: metformin arm
83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
 Drug: Metformin
83 patients will continue metformin until end of 1st trimester
Other Name: cidophage
Placebo Comparator: control arm
83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
 Drug: Metformin
83 patients will continue metformin until end of 1st trimester
Other Name: cidophage


Outcome Measures
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Primary Outcome Measures :
  1. Miscarriage Rate [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02498522


Locations
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Egypt
Faculty of Medicine, Ain Shams University
Cairo, Al Qahirah, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ahmed M kotb, MD Ain Shams University
More Information
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Responsible Party: Islam Dabbous, doctor, Ain Shams University
ClinicalTrials.gov Identifier: NCT02498522    
Other Study ID Numbers: Metformin in pregnancy
First Posted: July 15, 2015    Key Record Dates
Results First Posted: May 19, 2016
Last Update Posted: May 19, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Abortion, Spontaneous
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
 Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs