Clinical trial · Interventional
Metformin in Assisted Reproduction-MET-AR-study
Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
NCT00159575CI-TRIAL-00006006terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow patient recruitment and expiry of study medication(aug2009)
Summary
Brief summary (as posted)
Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index \[BMI\] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.
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 / Placebo treatment for 4 months | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- M: Metformin P: Placebo
- interventionNames
- Drug: Metformin / Placebo treatment for 4 months
Primary outcomes (1)
- measure
- To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women
- timeFrame
- Vaginal ultrasound in pregnancy week 7
Secondary outcomes (2)
- measure
- Spontaneous pregnancy rates during the pretreatment period, Spontaneous abortion rates (I or II trim.abortions), Live birth rates,
- timeFrame
- Vaginal ultrasound in pregnancy week 7
- measure
- Number of oocytes collected, Embryo quality, Number of days of gonadotrophin treatment, Dose of gonadotrophin, total per cycle and daily, s-estradiol on day of hCG-administration, Occurrence of ovarian hyperstimulation syndrome (OHSS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
Inclusion Criteria: * Fulfilling Rotterdam criteria for PCOS * Infertility more than 1 year * First or second cycle of IVF/ICSI treatment * Age below 38 years at inclusion * BMI below 28 kg/m3 at inclusion * Willing to be randomised to 4 months metformin or placebo * Signed written informed consent Exclusion Criteria: * Not suitable for starting dose 112.5 IE * Basal FSH above 10 IU/L * Known renal disease or s-creatinine above 110 umol/L * Known liver disease or s-ALAT above 80 IU/L * Known alcoholism or drug abuse * Known diabetes mellitus or fasting plasma glucose above 7 mmol/L * Corticosteroid treatment (oral) * Treatment with cimetidine, anticoagulants, erythromycin or other macrolides * Hyperprolactinemia (PRL above 700 mIU/L) * Abnormal thyroid function tests * Known congenital adrenal hyperplasia * Androgen secreting tumours * Cushing syndrome * Metformin treatment within the last one month prior to screening * Unfit to participate for any other reason
References
Publications (2)
- RESULTKjotrod SB, Carlsen SM, Rasmussen PE, Holst-Larsen T, Mellembakken J, Thurin-Kjellberg A, Haapaniemikouru K, Morin-Papunen L, Humaidan P, Sunde A, von During V. Use of metformin before and during assisted reproductive technology in non-obese young infertile women with polycystic ovary syndrome: a prospective, randomized, double-blind, multi-centre study. Hum Reprod. 2011 Aug;26(8):2045-53. doi: 10.1093/humrep/der154. Epub 2011 May 23. PMID 21606131
- DERIVEDTso LO, Costello MF, Albuquerque LET, Andriolo RB, Macedo CR. Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD006105. doi: 10.1002/14651858.CD006105.pub4. PMID 33347618