Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
MIP
1 other identifier
interventional
166
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2015
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
May 19, 2016
CompletedMay 19, 2016
April 1, 2016
6 months
July 13, 2015
March 28, 2016
April 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Miscarriage Rate
6 months
Study Arms (2)
metformin arm
EXPERIMENTAL83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
control arm
PLACEBO COMPARATOR83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Interventions
83 patients will continue metformin until end of 1st trimester
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ahmed kotb
- Organization
- AinShamsU
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed M kotb, MD
Ain Shams University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
July 13, 2015
First Posted
July 15, 2015
Study Start
August 1, 2015
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
May 19, 2016
Results First Posted
May 19, 2016
Record last verified: 2016-04