The RESPONSE trial
The RESPONSE trial results: NT100 (a man-made form of a protein called G-CSF) did not improve outcomes in women with a history of unexplained recurrent miscarriages.
RESPONSE was a randomised, double-blind, placebo controlled clinical trial (see box below) involving 150 women with a history of unexplained recurrent pregnancy loss. It was conducted at 21 UK hospitals between 23 June 2014 and 05 June 2016 and coordinated by the University of Birmingham. The Miscarriage Association’s National Director was a lay member of the Trial Oversight Group.
Of the 150 women who took part in the trial, 76 were randomised to NT100 (recombinant human granulocyte – colony stimulating factor, or G-CSF) and 74 to placebo. Treatment began from as early as three to five weeks gestation for a maximum of 9 weeks.
The results* showed no significant increase in clinical pregnancy or live births with the use of NT100 in the first trimester of pregnancy.There were also no significant differences between the treatment and placebo groups in any of the additional areas studied, including miscarriages, livebirth, adverse events, stillbirth, neonatal birth weight, major congenital anomalies or preterm births.
* Published in Human Reproduction on 18 Feb 2019.