Use of GM-CSF Treatment in Recurrent Implantation Failure
NCT ID: NCT01715974
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
140 participants
INTERVENTIONAL
2017-12-12
2022-08-31
Brief Summary
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Detailed Description
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The study will be conducted in 100 women with recurrent implantation failure of egg donation cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts where at least 4 good blastocysts were transferred, women less than 50 years old, absence of systemic diseases. These women will undergo egg donation cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous GM-CSF 60 micrograms/day from the day of transfer to the day of β-hCG test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcomes will be considered: pregnancy rate and live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo transfer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CONTROL
patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
CONTROL
saline infusion every day from the day of embryo transfer through the day of beta HCG test
GM-CSF group
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
GM-CSF group
30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test
Interventions
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GM-CSF group
30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test
CONTROL
saline infusion every day from the day of embryo transfer through the day of beta HCG test
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with a total of at least 4 blastocysts replaced in uterus
Exclusion Criteria
* metabolic diseases (diabetes etc.)
* genetic diseases (thalassemia, cystic fibrosis, etc.)
20 Years
50 Years
FEMALE
No
Sponsors
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Centre for Endocrinology and Reproductive Medicine, Italy
NETWORK
Responsible Party
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Principal Investigators
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Marco Sbracia, MD
Role: STUDY_CHAIR
Centre for Endocrinology and Reproductive Medicine, Italy
Locations
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Cerm-Hungaria
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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HC0003
Identifier Type: -
Identifier Source: org_study_id
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