Use of GM-CSF Treatment in Recurrent Implantation Failure
Administration of GM-CSF in Women With Recurrent Implantation Failure in IVF Cycles and Egg Donation Cycles
1 other identifier
interventional
140
1 country
1
Brief Summary
The purpose of this study is to determine whether in Assisted Reproductive Technologies the treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2017
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedStudy Start
First participant enrolled
December 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJuly 20, 2022
July 1, 2022
4.6 years
March 2, 2012
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pregnancy outcome
The number of patients pregnant after treatment with GM-CSF (30 microgram/day)compared with the number of patients pregnant in the control group
12 months
Secondary Outcomes (1)
implantation rate
12 months
Study Arms (2)
CONTROL
PLACEBO COMPARATORpatients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
GM-CSF group
EXPERIMENTALpatients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test
Interventions
30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test
saline infusion every day from the day of embryo transfer through the day of beta HCG test
Eligibility Criteria
You may qualify if:
- women 50 years old or less with three or more previous egg donation cycles failed,
- with a total of at least 4 blastocysts replaced in uterus
You may not qualify if:
- chromosomal defects in the patients,
- metabolic diseases (diabetes etc.)
- genetic diseases (thalassemia, cystic fibrosis, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cerm-Hungaria
Rome, 198, Italy
Related Publications (2)
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: 19617208BACKGROUNDScarpellini F, Sbracia M, Marconi D, Fracassi A, Santi K, Desole E. A Randomised Controlled Trial on the Treatment of Recurrent Implantation Failure Women Who Failed Egg Donation Cycles Using Low-Dose GM-CSF. Am J Reprod Immunol. 2025 Sep;94(3):e70162. doi: 10.1111/aji.70162.
PMID: 40965804DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marco Sbracia, MD
Centre for Endocrinology and Reproductive Medicine, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2012
First Posted
October 29, 2012
Study Start
December 12, 2017
Primary Completion
July 31, 2022
Study Completion
August 1, 2022
Last Updated
July 20, 2022
Record last verified: 2022-07