Early Phase 1
Completed N=170
Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
Source: ClinicalTrials.gov NCT02498522 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Miscarriage Rate — 9; 35 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Miscarriage Rate |
9; 35 | — |
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. Informational only — not medical advice.