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Completed

NCT Number: NCT01046032

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

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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Key information

Age range

Up to 38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVF Hammersmith, London, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Oligo- or amenorrhoea with cycles ≥42 days apart.
  • Anovulation with mid-luteal progesterone <16 nmol/L.
  • Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index >5 (FAI = [total testosterone/SHBG] x 100).
  • 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.

Treatment and study plan

metformin

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. Live birth rate

    Time frame: End of pregnancy

Secondary outcomes

  1. Severe ovarian hyperstimulation syndrome

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Imperial College London
  • University of Nottingham

Registry information

Official study title

Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jan 11, 2010
Registry last updated
Jan 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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