The RESPONSE trial

The RESPONSE trial is testing a new medication, called NT100, in women with unexplained repeated miscarriages.  They want to find out if it improves the chances of maintaining a successful pregnancy, if there are any side effects of the medicine and if it is easy to use.

N.B. The RESPONSE trial has now ended.  We look forward to learning the results of the trial – likely to be published in Spring or Summer 2017.

NT100 is a man-made form of a protein called G-CSF (granulocyte colony-stimulating factor).  G-CSF is a naturally occurring protein in the female reproductive tract.

RESPONSE is a randomised, double-blind, placebo-controlled trial:

Randomised: The women who take part will be given either the treatment medicine (NT100) or a placebo – a dummy drug that has no active ingredients.  A computer makes the selection so it’s completely random.

Double-blind The women in the trial won’t be told whether they are taking the active medicine (NT100) or the placebo – and neither will their doctors.  So both are “blinded” to this information.

Placebo-controlled Half of the women in the study will have the active medicine and half the placebo (they are called the control group).  The medication that they receive will look exactly the same to them and their doctors, but a completely separate study group will keep a record of which women have NT100 and which have the placebo.

If you might be interested in taking part in the RESPONSE trial, here’s what you need to know

Who can take part

You may be eligible for the RESPONSE trial if you:

  • are between 18 and 37 years old
  • have had three or more unexplained miscarriages:
    • it doesn’t matter if they were consecutive (one after the other) or not
  • want to try for another pregnancy.

What the trial involves

Women taking part in the trial will need to use ovulation tests and urine pregnancy tests while trying to conceive.  These will be given to you by the research study team.

Once you are pregnant, you will need to make up to 12 clinic visits during your pregnancy.  You will be able to claim back reasonable travel expenses, such as public transport or parking costs.

Which hospitals are taking part

The following hospitals are recruiting patients:

  • Ashington, Northumberland Wansbeck Hospital
  • Birmingham City Hospital
  • Birmingham Heartlands Hospital
  • Birmingham Women’s NHS Foundation Trust
  • Chertsey Ashford & St Peter’s Hospital
  • Coventry & Warwickshire University Hospitals
  • Edinburgh Edinburgh Royal Infirmary
  • Frimley, Surrey  FrimleyPark Hospital
  • Leeds St James’s University Hospital
  • Liverpool Women’s Hospital
  • London Guys Hospital
  • London St Mary’s Hospital
  • Manchester St Mary’s Hospital
  • Middlesborough James Cook University Hospital
  • Newcastle Royal Victoria Infirmary
  • Nottingham Nottingham University Hospitals
  • Oxford John Radcliffe Hospital
  • Plymouth Derriford Hospital
  • Southampton Princess Ann Hospital
  • South Shields South Tyneside District Hospital
  • Sunderland Royal Hospital
  • Wirral  Arrowe Park Hospital

If you have any questions that are not medical or scientific and more about feelings or concerns about the trial, do contact us at info@miscarriageassociation.org.uk or call us on 01924 200799.