Clinical trial · Interventional
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
NCT03259919CI-TRIAL-00035364pilPregMetcompletedPhase 2ClinicalTrials.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)
To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Metformin 850 mg x 2 daily
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Placebo 1 tablet x 2 daily
- interventionNames
- Drug: Placebo
Primary outcomes (5)
- measure
- Dehydroepiandrosterone sulfate (DHEAS)
- timeFrame
- up to delivery
- description
- (µmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis polycystic ovary syndrome (PCOS ) before pregnancy * BMI 27-40 kg/m2 * Human chorionic gonadotropin, beta subunit (HCG-beta) verified pregnancy week 5-8 * At least one of the following criteria: (1) serum testosteron \> 2,5 nmol/L; (2) Sex hormone binding globulin (SHBG) \< 30 nmol; (3) Fasting C-peptid \> 1,0 nmol/L; (4) Menstrual disturbances: oligo-/amenorrhea or metrorrhagia; (5) Hirsutism Exclusion Criteria: * known liver disease or ALAT \> 60 IU/L * S-creatinin \> 130 micromol/L * diabetes mellitus * alcohol or drug abuse * peroral steroid treatment (except inhalation steroids) * use of cimetidine, anticoagulant, erythromycin or other macrolides * not suitable for other reasons
References
Publications (8)
- RESULTVanky E, Salvesen KA, Heimstad R, Fougner KJ, Romundstad P, Carlsen SM. Metformin reduces pregnancy complications without affecting androgen levels in pregnant polycystic ovary syndrome women: results of a randomized study. Hum Reprod. 2004 Aug;19(8):1734-40. doi: 10.1093/humrep/deh347. Epub 2004 Jun 3. PMID 15178665
- RESULTHanem LGE, Stridsklev S, Juliusson PB, Salvesen O, Roelants M, Carlsen SM, Odegard R, Vanky E. Metformin Use in PCOS Pregnancies Increases the Risk of Offspring Overweight at 4 Years of Age: Follow-Up of Two RCTs. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1612-1621. doi: 10.1210/jc.2017-02419. PMID 29490031
- DERIVEDRyssdal M, Skage JE, Jarmund AH, Hanem LGE, Lovvik TS, Giskeodegard GF, Iversen AC, Vanky E. Metformin Treatment in PCOS Pregnancies Reduces Maternal Infections and Increases the Risk of Allergies and Eczema in the Offspring: Post Hoc Analyses of Two Randomised Controlled Trials and One Follow-Up Study. BJOG. 2025 Nov;132(12):1823-1832. doi: 10.1111/1471-0528.18320. Epub 2025 Aug 11. PMID 40785326
- DERIVEDNordtvedt E, Kessler J, Ebbing C, Acharya G, Lovvik TS, Salvesen KA, Salvesen O, Vanky E, Kahrs BH. Placental and cerebral circulation in fetuses of mothers with polycystic ovary syndrome and the effect of Metformin exposure. BMC Pregnancy Childbirth. 2025 Jul 10;25(1):749. doi: 10.1186/s12884-025-07866-9. PMID 40640743
- DERIVEDUjvari D, Trouva A, Hirschberg AL, Vanky E. Maternal serum levels of prokineticin-1 related to pregnancy complications and metformin use in women with polycystic ovary syndrome: a post hoc analysis of two prospective, randomised, placebo-controlled trials. BMJ Open. 2023 Nov 21;13(11):e073619. doi: 10.1136/bmjopen-2023-073619. PMID 37989369
- DERIVEDTrouva A, Alvarsson M, Calissendorff J, Asvold BO, Vanky E, Hirschberg AL. Thyroid Status During Pregnancy in Women With Polycystic Ovary Syndrome and the Effect of Metformin. Front Endocrinol (Lausanne). 2022 Feb 21;13:772801. doi: 10.3389/fendo.2022.772801. eCollection 2022.