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

NCT00772122 | Completed Phase 4 DMC

• 1 other identifier: CERM0103
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Habitual Abortion

Keywords

Recurrent Miscarriage; G-CSF; pregnancy outcome; pregnancy outcome of pregnancies treated with G-CSF; treatment of recurrent miscarriage

Outcome Measures

Primary Outcomes (1)

• Pregnancy outcome

  During the treatment

Secondary Outcomes (1)

• Pregnancy complication, undesired effects

  during treatment

Study Arms (2)

Granulocyte colony stimulating factor

EXPERIMENTAL

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

placebo (saline solution)

PLACEBO COMPARATOR

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

Interventions

G-CSF DRUG

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.

Also known as: filgrastim (Neupogen, Dompe', Italy),

Granulocyte colony stimulating factor

saline solution DRUG

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.

placebo (saline solution)

Eligibility Criteria

• Age: 25 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• in the last abortion a fetal karyotype showing chromosomal abnormality
• previous successful pregnancy

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

CERM

Rome, 00198, Italy

Location

Related Publications (1)

• 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.

  PMID: 19617208 DERIVED

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; Saline Solution

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Fabio Scarpellini, MD

  Centre for Endocrinology and Reproductive Medicine, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 15, 2008
• Study Start: January 1, 2000
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: October 15, 2008

Record last verified: 2008-10

Locations

IT (1)