NCT01715974|UnknownPhase 3DMC
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
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Sponsor study identifier
interventional
140
1 country
1
Study Start
December 12, 2017
Actual (reported)Primary Completion
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2012
Actual (reported)October 29, 2012
Actual (reported)December 12, 2017
Actual (reported)July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
implantation rate
12 months
patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
patients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test
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
Cerm-Hungaria
Rome, 198, Italy
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.
Scarpellini 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.
Marco Sbracia, MD
Centre for Endocrinology and Reproductive Medicine, Italy
First Submitted
March 2, 2012
First Posted
October 29, 2012
Study Start
December 12, 2017
Actual (reported)Primary Completion
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Determining the Effect of an "Alternate Recovery Protocol" Versus Current Standard of Care After Cesarean Section
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
August 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 20, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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