Metformin and GnRH Antagonist co-treatment in IVF for women with PCOS

• Research type

  Research Study

• Full title

  The use of Metformin and Gonadotrophin Releasing Hormone Antagonist for the treatment of women with Polycystic Ovary Syndrome undergoing In-vitro Fertilisation-Embryo Transfer.

• IRAS ID

  13737

• Sponsor organisation

  THE LEEDS TEACHING HOSPITALS NHS TRUST

• Eudract number

  2009-010952-81

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Couples attending for subfertility treatment may require in vitro fertilisation (IVF). A high proportion of women who attend for IVF have polycystic ovary syndrome (PCOS) or the appearance of polycystic ovaries (PCO) on ultrasonography. These women are at particular risk of developing a complication of IVF treatment, Ovarian Hyperstimulation Syndrome (OHSS). OHSS can cause serious ill-health and rarely even death. It is therefore of vital importance that all measures are taken to avoid OHSS and minimise the chance of it occurring. The addition of the drug metformin has been shown to reduce the risk of OHSS in women with PCOS/PCO when undergoing IVF treatment following the Ó?long-protocol?. It is the aim of this study to demonstrate that the addition of metformin to the treatment regime for the Ó?short gonadotrophin releasing hormone (GnRH) antagonist protocol? also reduces the rates of OHSS. In addition to this we hope to demonstrate that it improves other outcome measures of successful IVF treatment.The proposed study will demonstrate this using a randomised double-blind placebo controlled trial of metformin vs placebo in the context of a short GnRH antagonist IVF treatment protocol for women with PCOS.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/52

• Date of REC Opinion

  11 Jun 2009

• REC opinion

  Further Information Favourable Opinion