Clinical trial · Interventional
Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
NCT02498522CI-TRIAL-00022302MIPcompletedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- metformin arm
- description
- 83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- control arm
- description
- 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Miscarriage Rate
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.