Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium
      will increase the chance of a pregnancy after in vitro fertilisation.
    

Detailed description: 
      Throughout its development, the embryo is naturally exposed to a large number of cytokines
      and growth factors that are present in the woman's reproductive organs. A growing body of
      evidence indicates that these factors play a physiological role in the regulation of normal
      development of the pre-implanted embryo and that these factors therefore help to increase the
      implantation of the embryo and subsequently ensure optimal development of both foetus and
      placenta. The cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) has been
      shown to be present in the female reproductive organs during early pregnancy in mice, sheep,
      cows and humans.

      2 ng/ml GM-CSF has been proven safe in a previous study presented at the European Society of
      Human Reproduction and Embrylogy (ESHRE) congress 2007 (A. Loft et al. 2007).

      The present investigation (DK001) is to our knowledge the first large prospective randomised
      in vivo study in humans. Previous publications counting one Korean pilotstudy of 154 women
      prospectively randomised between culture medium with and without GM-CSF 2 ng/ml (Kim et al.,
      2001), showing a significant effect of GM-CSF on embryo implantation rate.

      Based on this knowledge we hypothesize that culture of human embryos in the presence of
      GM-CSF will significantly increase the implantation rate also in a larger population.

      This hypothesis is being tested by conducting a multicentre, randomised, parallel group,
      double-blind, placebo-controlled study with adaptive design, performed at 14 study centres.
      Each patient will participate in the study from retrieval of oocytes following standard
      hormonal treatment and until the 12th gestational week. Further a follow-up will be performed
      on pregnancies and children born.

      The test group will include a standard culture medium with 2 ng/ml GM-CSF added from the time
      of insemination, and the control group will be the exact same medium but without any
      additions.

      All procedures are according to standards of the clinic, with applied standard media except
      for the patient randomised study medium which is used for oocyte insemination, embryo culture
      and transfer. Embryo transfer will be performed Day 3.

      An interim analysis has been performed for final sample size calculation.
    

Intervention name(s): Test culture; Control culture
Intervention type(s): Device; Device
Intervention description(s): A standard culture medium with added GM-CSF (ready-to-use); The same standard culture medium, but without any additions (ready-to-use)
Other intervention name(s): EmbryoGen; EmbryoAssist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GM-CSF; infertility