Early Phase 1
N=170
Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02498522 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Miscarriage Rate — 9; 35 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Metformin (Drug)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Ain Shams University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Miscarriage Rate |
9; 35 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT02498522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.