Use of G-CSF for the Treatment of Unexplained Recurrent Miscarriage

Summary

In order to investigate the effectiveness of G-CSF in preventing embryo demise, the investigators administered this cytokine to women with recurrent miscarriage in a randomized controlled study compared to women treated with placebo. Sixty eight women with unexplained primary recurrent miscarriage, all of them with at least four consecutive abortions and negative for all clinical investigations were selected for this study. Patients were randomly treated with G-CSF, starting on the 6th day after ovulation, or with placebo.

Timeline

Start

2000-01

Primary completion

2007-01

Completion

2007-01

Outcome

Met primary endpoint

paper 29 out of 35 (82.8%) women delivered a healthy baby, whereas in the placebo group, this figure was only 16 out of 33 (48.5%) PMID 19617208 ↗

paper (P = 0.0061, odds ratio = 5.1; 95% confidence interval 1.5-18.4). PMID 19617208 ↗

Publications

• Scarpellini F, Sbracia M. Use of granulocyte colony-stimulating factor for the treatment of unexplained recurrent miscarriage: a randomised controlled trial. Hum Reprod. 2009 Nov;24(11):2703-8. doi: 10.1093/humrep/dep240. Epub 2009 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	filgrastim	Protein / enzyme biologic	1 ug/kg	Subcutaneous

Indications