- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01715974
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
Study Overview
Status
Intervention / Treatment
Detailed Description
The GM-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after IVF, at leat three failed previous IVF attempts.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: MARCO SBRACIA, MD
- Phone Number: +393479037433
- Email: marcandrea@hotmail.com
Study Contact Backup
- Name: Fabio Scarpellini, MD
- Phone Number: +393278779064
- Email: marcandrea@hotmail.com
Study Locations
-
-
-
Rome, Italy, 198
- Recruiting
- Cerm-Hungaria
-
Contact:
- MARCO SBRACIA, MD
- Phone Number: +393479037433
- Email: marcandrea@hotmail.com
-
Contact:
- Fabio Scarpellini, MD
- Phone Number: +393278779064
- Email: marcandrea@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- chromosomal defects in the patients,
- metabolic diseases (diabetes etc.)
- genetic diseases (thalassemia, cystic fibrosis, etc.)
Study Plan
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 |
---|---|
Placebo Comparator: CONTROL
patients with recurrent implantation failure treated with PLACEBO (saline solution) 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
Other Names:
|
Experimental: 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
|
30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pregnancy outcome
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
implantation rate
Time Frame: 12 months
|
number of embryos implanted
|
12 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HC0003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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