rhG-CSF Does Not Improve Pregnancy Outcomes in Women With History of Unexplained Recurrent Pregnancy Loss: Presented at ESHRE

By Chris Berrie

BARCELONA, Spain -- July 6, 2018 -- Recombinant human granulocyte-colony-stimulating factor (rhG-CSF) is safe but does not improve pregnancy outcomes compared with placebo for women with history of unexplained recurrent pregnancy loss, according to a study presented here at the 34th Annual Meeting of the European Society for Human Reproduction and Embryology (ESHRE).

In the study, the clinical pregnancy rate at 20 weeks, as well as the live birth rate, was 59.2% in the rhG-CSF group (45/76), and 64.9% in the placebo group (48/74),

There was no evidence of a significant difference between the groups for any of the secondary outcomes, reported Abey Eapen, MD, University of Iowa Carver College of Medicine, Iowa City, Iowa.

The study included women aged 18 to 37 years who were actively trying to conceive naturally after being diagnosed with a history of unexplained recurrent pregnancy losses. The participants were recruited from 21 hospitals from across the United Kingdom.

Immediately following positive urine pregnancy test, women were randomised to daily subcutaneous injections of placebo or rhG-CSF 130 mcg.

There were no significant difference for live birth rates (64.9% vs 59.2%) and there were no intrauterine or neonatal deaths.

“Thus there were no clinical effects for rhG-CSF seen,” said Dr. Eapen. “We now have high quality evidence suggesting that rhG-CSF is not an effective treatment for patients with unexplained recurrent miscarriages.”

A limitation of the study was that participants were not screened prior to inclusion to demonstrate immune dysfunction as the reason for their pregnancy losses.

Funding for this study was provided by Nora Therapeutics, Inc.

[Presentation title: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) in Women With Unexplained Recurrent Pregnancy Loss – RESPONSE Trial. Abstract O-185]

To read more Conference Dispatch articles, click here.