G-CSF Treatment in Unexplained Recurrent Pregnancy Loss: Results of a Controlled Trial on 120 Women and Total Data on Ten Years Experience

Background: We used successfully G-CSF in the treatment of unexplained Recurrent Pregnancy Loss (RPL), and we published these data in 2009.

Objective: We conducted a larger controlled trial on the use of G-CSF in the treatment of unexplained RPL women compared to placebo, and data on 270 unexplained RPL treated with G-CSF.

Methods: A controlled study on 120 unexplained RPL women from 2008 and 2010 was conducted; they were randomly assigned to two arms of study: the G-CSF group 66 women were treated with 0.1 mcg/kg/day from the day of ovulation through the 9^th week of gestation, the placebo group 54 women were treated with saline infusion in the same way of the others. We treated a total of 270 women.

Results: In the controlled trial the delivery of a healthy baby was observed in the 83.3% (55/66), whereas in the controls it was 44.4 (24/54) (P<0.0001). Furthermore, in the single arm study we evaluated 270 unexplained RPL women treated with G-CSF and we observed the delivery of a healthy baby in the 81.1% (219/270). In this group of patients were included 74 women with 3 RPL, 95 women with 4 RPL, 61women with 5 RPL, and 40 women with 6 or more RPL. These women in 91 cases were 35 or less years old, in 111 cases were in between 36 and 39 years old and in 68 cases 40 years or more old. The data showed that delivery rate after G-CSF treatment was significantly higher in women with 4 or more unexplained RPL (p<0.001), it was significantly higher also in women less than 40 years old (P<0.001). No major side effects were recorded.

Conclusion: Our data showed that G-CSF treatment in unexplained RPL is an effective therapy. It showed the maximum strength with the increase of the number of previous RPL and in patients with less than 40 years old.