Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome
NCT ID: NCT01587378
Last Updated: 2019-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
489 participants
INTERVENTIONAL
2012-10-31
2017-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators hypothesis is that metformin compared to placebo treatment from the first trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and preterm birth (gestational week \< 37) in PCOS women diagnosed according to Rotterdam 2003 consensus criteria, with singleton pregnancy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Metformin in Pregnant PCOS Women
NCT00159536
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
NCT03259919
The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS)
NCT00994812
Metformin in Assisted Reproduction-MET-AR-study
NCT00159575
Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization
NCT01208740
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
metformin
Metformin
Metformin 500 mg tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
placebo
placebo
identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin
Metformin 500 mg tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
placebo
identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion
* Mode of conception: Any
* Single, viable fetus, diagnosed by vaginal ultrasound
* Gestational week at inclusion: week 6 + 0 to 12 + 0
* Wash out for metformin: at least 7 days
* Able to communicate fluently in the official language at the study cite or English
Exclusion Criteria
* Known liver disease or ALAT \> 100 IU/L
* Known kidney disease or creatinine \> 110 μmol/L
* Known alcohol or drug abuse
* Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidine, anticoagulation therapy
* Unsuitable for participation of other reasons
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vestre Viken Hospital Trust
OTHER
Landspitali University Hospital
OTHER
Uppsala University Hospital
OTHER
Haukeland University Hospital
OTHER
Karolinska University Hospital
OTHER
St. Olavs Hospital
OTHER
Sykehuset Telemark
OTHER_GOV
Alesund Hospital
OTHER
The Hospital of Vestfold
OTHER
Nordlandssykehuset HF
OTHER
Norrlands universitetssjukhus Umeå
UNKNOWN
Sykehuset Innlandet HF
OTHER
Vestre Viken Ringerike Sykehus
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eszter I Vanky, md phd
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Landspital University Hospital
Reykjavik, , Iceland
Sykehuset Ålesund
Ålesund, , Norway
Haukeland University Hospital
Bergen, , Norway
Nordlandssykehuset HF
Bodø, , Norway
Sykehuset Innlandet
Brumunddal, , Norway
Vestre Viken Hospital Trust
Drammen, , Norway
Vestre Viken Ringerike sykehus
Hønefoss, , Norway
Sykehuset Telemark
Skien, , Norway
St Olavs Hospital
Trondheim, , Norway
Sentralsykehuset i Vestfold
Tønsberg, , Norway
Karolinska Universitetssjukhus
Stockholm, , Sweden
Norrlands universitetssjukhus
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lovvik TS, Carlsen SM, Salvesen O, Steffensen B, Bixo M, Gomez-Real F, Lonnebotn M, Hestvold KV, Zabielska R, Hirschberg AL, Trouva A, Thorarinsdottir S, Hjelle S, Berg AH, Andrae F, Poromaa IS, Mohlin J, Underdal M, Vanky E. Use of metformin to treat pregnant women with polycystic ovary syndrome (PregMet2): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 Apr;7(4):256-266. doi: 10.1016/S2213-8587(19)30002-6. Epub 2019 Feb 18.
Ryssdal 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.
Nordtvedt 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.
Husby AE, Simpson MR, Dalbye R, Larsen M, Vanky E, Lovvik TS. Childbirth experiences in women with polycystic ovary syndrome: A cohort study. Acta Obstet Gynecol Scand. 2024 Jun;103(6):1092-1100. doi: 10.1111/aogs.14800. Epub 2024 Feb 17.
Stokkeland LMT, Giskeodegard GF, Ryssdal M, Jarmund AH, Steinkjer B, Madssen TS, Stafne SN, Stridsklev S, Lovvik TS, Iversen AC, Vanky E. Changes in Serum Cytokines Throughout Pregnancy in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2022 Jan 1;107(1):39-52. doi: 10.1210/clinem/dgab684.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-002203-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2011/1434
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.