Use of G-CSF for the Treatment of Unexplained Recurrent Miscarriage
Condition: Habitual Abortion
MeSH terms: Abortion, Spontaneous; Abortion, Habitual
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The patients with unexplained primary (no previous successful pregnancy) recurrent
      miscarriage (RM) referred to the Hungaria Center for Endocrinology and Reproductive Medicine
      between January 2000 to January 2007 were considered eligible for the study. The patients had
      to fulfil the following inclusion criteria: woman's age less than 39 years, more than 4
      previous abortions, failure of a previous treatment for RM (immunoglobulin infusion), and
      they had to be negative for the all the known causes of RM The study was reviewed and
      approved by the Institutional Review Board, and the clinical study was conducted according to
      Italian law and the Declaration of Helsinki for Medical Research involving Human Subjects. A
      sample size calculation showed that a total of 32 patient per group were needed in order to
      have a difference of 33% between the two groups a for p<0.005 and a beta>0.80 A total of 72
      patients were considered eligible for the study, and 68 of them agreed to participate,
      signing an informed consent form. All the patients were informed about the eventual potential
      risks of this treatment for the mother and the foetus, other than the lack of information
      about the developmental toxicity of G-CSF. The patients were randomized by means of a
      computer generated randomization number sequence. All the patients were informed about the
      therapy and they gave their written informed consent. They were randomly assigned to the two
      arms of the study, one to G-CSF treatment and the other to placebo administration; the
      patients were blind to which treatment they were assigned to. The G-CSF group of 35 women,
      underwent a daily sub-cutaneous administration of the filgrastim (Neupogen, Dompe', Italy),
      the recombinant G-CSF, at a dosage of 1 microgram (100000 IU)/kg/day from the 6th day after
      ovulation till the occurrence of menstruation or to the end of the 9th week of gestation. The
      placebo group consisting of 33 subjects, was given a treatment with subcutaneous saline
      solution at the dosage of 0.2 ml daily, and also in this case, from the 6th day after the
      ovulation till to the recurrence of menstrual loss or to the end of the 9th week. Primary
      outcome was considered the pregnancy outcome.
    

Intervention name(s): G-CSF; saline solution
Intervention type(s): Drug; Drug
Intervention description(s): daily sub-cutaneous administration of the recombinant G-CSF, at a dosage of 1 microgram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation.; daily sub-cutaneous administration of saline solution 0.2ml from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week.
Other intervention name(s): filgrastim (Neupogen, Dompe', Italy),
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Recurrent Miscarriage; G-CSF; pregnancy outcome; pregnancy outcome of pregnancies treated with G-CSF; treatment of recurrent miscarriage