Clinical trial · Interventional
Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries
Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study
NCT01046032CI-TRIAL-00002995completedN/AClinicalTrials.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 study was to investigate whether pre-treatment with metformin before and during IVF increases the live birth rate compared to placebo in women with sonographic evidence of polycystic ovaries (PCO), but without any clinical manifestations of 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metformin
- description
- Drug (including placebo)
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- Sugar pill
- description
- Drug (including placebo)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Live birth rate
- timeFrame
- End of pregnancy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 38 Years
Show eligibility criteria text
Inclusion Criteria: * Women attending with ovulatory PCO due to undergo IVF/ICSI treatment. * First or second cycle of IVF/ICSI. * If previously on metformin, a minimum one month washout period was required. * Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm in diameter in at least one ovary and/or increased ovarian volume (≥10 ml). * Written informed consent. Exclusion Criteria: * Clinical manifestations of PCOS, including any of the following: 1. Oligo- or amenorrhoea with cycles ≥42 days apart. 2. Anovulation with mid-luteal progesterone \<16 nmol/L. 3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index \>5 (FAI = \[total testosterone/SHBG\] x 100). 4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly. * Age \>38 years. * BMI \>35 kg/m2. * Basal FSH \>12 IU/L. * Liver disease or ALT \>80 IU/L. * Renal disease, or creatinine \>130 nmol/L. * Alcoholism or drug abuse. * Diabetes mellitus (evaluated by fasting glucose \>6.7mmol/L). * Per oral steroid treatment in last month. * Cimetidine, anticoagulation, erythromycin, or other macrolides in last month. * Hyperprolactinemia (Prolactin \>700 mIU/L). * Abnormal thyroid function tests (TSH outside of laboratory normal range). * Congenital adrenal hyperplasia.
References
Publications (3)
- BACKGROUNDTang T, Glanville J, Orsi N, Barth JH, Balen AH. The use of metformin for women with PCOS undergoing IVF treatment. Hum Reprod. 2006 Jun;21(6):1416-25. doi: 10.1093/humrep/del025. Epub 2006 Feb 24. PMID 16501038
- BACKGROUNDKjotrod SB, von During V, Carlsen SM. Metformin treatment before IVF/ICSI in women with polycystic ovary syndrome; a prospective, randomized, double blind study. Hum Reprod. 2004 Jun;19(6):1315-22. doi: 10.1093/humrep/deh248. Epub 2004 Apr 29. PMID 15117902
- DERIVEDSwanton A, Lighten A, Granne I, McVeigh E, Lavery S, Trew G, Talmor A, Raine-Fenning N, Jayaprakasan K, Child T. Do women with ovaries of polycystic morphology without any other features of PCOS benefit from short-term metformin co-treatment during IVF? A double-blind, placebo-controlled, randomized trial. Hum Reprod. 2011 Aug;26(8):2178-84. doi: 10.1093/humrep/der120. Epub 2011 May 18. PMID 21593045