Back to resultsEffect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome (MIP)
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Polycystic Ovary Syndrome
Eligibility 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.
Sites / Locations
- Faculty of Medicine, Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
metformin arm
control arm
Arm Description
83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Outcomes
Primary Outcome Measures
Miscarriage Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02498522
Brief Title
Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
Acronym
MIP
Official Title
Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin arm
Arm Type
Experimental
Arm Description
83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
Arm Title
control arm
Arm Type
Placebo Comparator
Arm Description
83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
cidophage
Intervention Description
83 patients will continue metformin until end of 1st trimester
Primary Outcome Measure Information:
Title
Miscarriage Rate
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M kotb, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Ain Shams University
City
Cairo
State/Province
Al Qahirah
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
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