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CompletedNCT01046032Updated Jan 11, 2010

Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries

An interventional study of Metformin and Placebo in Polycystic Ovary Syndrome, sponsored by University of Oxford. Completed at 3 sites in United Kingdom. Open to female participants aged Up to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-11.

Sponsored by University of Oxford · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
Up to 38 Years
Sex
Female
01

Study summary

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).

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Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Polycystic ovaries
  • Ovarian stimulation
  • IVF
  • Ovarian hyperstimulation
  • Metformin
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 134 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
134 participants (actual)

Study arms

  • Active comparator
    Metformin

    Drug (including placebo)

    Drug: Metformin

  • Placebo comparator
    Sugar pill

    Drug (including placebo)

    Drug: Placebo

Interventions

  • DrugMetformin

    Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.

  • DrugPlacebo

    Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.

06

What researchers measure

Primary outcomes

  1. Live birth rate

    Time frame: End of pregnancy

Secondary outcomes

  1. Severe ovarian hyperstimulation syndrome

    Time frame: 2 months

07

Study locations

3 sites
  • IVF Hammersmith
    London, United Kingdom
  • Nuture IVF Unit
    Nottingham, United Kingdom
  • Oxford Fertility Unit
    Oxford, OX39DU, United Kingdom
08

References and documents

Publications

  • Tang 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. PubMed 16501038 ↗
  • Kjotrod 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. PubMed 15117902 ↗
  • Swanton 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. PubMed 21593045 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01046032
Lead sponsor
University of Oxford
Collaborators
Imperial College London, University of Nottingham
First posted
Jan 11, 2010
Start date
Dec 2005
Primary completion
May 2009
Completion
May 2009
Last update
Jan 11, 2010

Study contacts

Tim J Child, MA MD MRCOG
study director · University of Oxford
Alexander G Swanton, MBBS MRCOG
principal investigator · University of Oxford

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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