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

This study has been completed.
Sponsor:
Information provided by:
University of Florence
ClinicalTrials.gov Identifier:
NCT00772122
First received: October 10, 2008
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Habitual Abortion
Drug: G-CSF
Drug: saline solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Controlled Trial in Women With Recurrent Miscarriage of G-CSF Versus Placebo

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • Pregnancy outcome [ Time Frame: During the treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pregnancy complication, undesired effects [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: January 2000
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Granulocyte colony stimulating factor
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 micro gram (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.
Drug: G-CSF
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.
Other Name: filgrastim (Neupogen, Dompe', Italy),
Placebo Comparator: placebo (saline solution)
The placebo group consisting of 33 subjects, was given a treatment with saline solution at the 0.2ml/day subcutaneously/, from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week.
Drug: saline solution
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 Name: saline solution

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.

  Eligibility

Ages Eligible for Study:   25 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • four or more previous consecutive abortion,
  • failed previous treatment with intravenous immunoglobulins
  • negative to all clinical investigation for recurrent miscarriage

Exclusion Criteria:

  • in the last abortion a fetal karyotype showing chromosomal abnormality
  • previous successful pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772122

Locations
Italy
CERM
Rome, Italy, 00198
Sponsors and Collaborators
University of Florence
Investigators
Principal Investigator: Fabio Scarpellini, MD Centre for Endocrinology and Reproductive Medicine, Italy
  More Information

No publications provided by University of Florence

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scarpellini Fabio, CERM
ClinicalTrials.gov Identifier: NCT00772122     History of Changes
Other Study ID Numbers: CERM0103
Study First Received: October 10, 2008
Last Updated: October 14, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by University of Florence:
Recurrent Miscarriage
G-CSF
pregnancy outcome
pregnancy outcome of pregnancies treated with G-CSF
treatment of recurrent miscarriage

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Pharmaceutical Solutions
Lenograstim
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014