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Phase I/II ENdometrial TIssue REgeneration (ENTIRE)
• Promotor: Igenomix
• Prospective, Controlled, non-randomized trial (n=20 patients or 35 transferred embryos)
• Centers:
o IVI Barcelona/IVI Valencia (Hysteroscopy and ART)
o Hospital Universitari Vall d’Hebron (Hematology Department, Radiology Department, and Ob/Gyn) o Banc de Sang i Teixits de Catalunya (BST)
• Objectives:
o Defining effective dosage, safety and security
• Inclusion Criteria
o 18-44 year-old patients
o BMI <30
o Moderate-Severe AS patients with no improvement after surgical treatment
o ART egg donation in blastocyst stage or euploid vitrified bastocysts with own eggs
Phase I/II ENdometrial TIssue REgeneration (ENTIRE)
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Primary Endpoint
• Assessment of Adverse Events (Safety and Tolerability) Secondary Outcomes
Hysteroscopy
Endometrial Receptivity Analysis (ERA)
Endometrial Biopsy (IF) Microbiota Assessment DNA Analysis
• • •
Determining most effective Dosage for the treatment ART Outcomes (Effectiveness)
Measure Endometrial Receptivity and impact in the therapy in endometrium
Hysteroscopy
Endometrial Receptivity Analysis (ERA)
Endometrial Biopsy (IF) Microbiota Assessment
PRECONGRESS COURSE 10 I BARCELONA, SPAIN – 1 JULY 2018 117