Use of G-CSF for the Treatment of Unexplained Recurrent Miscarriage
October 14, 2008 updated by: University of Florence
Controlled Trial in Women With Recurrent Miscarriage of G-CSF Versus Placebo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rome, Italy, 00198
- CERM
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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 Names:
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pregnancy outcome
Time Frame: During the treatment
|
During the treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pregnancy complication, undesired effects
Time Frame: during treatment
|
during treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fabio Scarpellini, MD, Centre for Endocrinology and Reproductive Medicine, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
October 10, 2008
First Submitted That Met QC Criteria
October 14, 2008
First Posted (Estimate)
October 15, 2008
Study Record Updates
Last Update Posted (Estimate)
October 15, 2008
Last Update Submitted That Met QC Criteria
October 14, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERM0103
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