This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.
This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6). Patients are allocated through computer-generated randomization into one of the three groups: Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer (pET) after identification of the personalized window of implantation using the endometrial receptivity analysis (ERA) test, all of them following the usual clinical practice in a same-cycle embryo transfer. A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with elective blastocyst transfer are randomized in this prospective, multicenter, open label and controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
569
Centre of Reproductive Medicine UZ Brussles
Brussels, Belgium
Centro de Infertilidade e Medicina Fetal do Norte Fluminence
Campos dos Goytacazes, Rio de Janeiro, Brazil
Centro de Reproduçao Humana Nilo Frantz
Live birth delivery rate
Percentage of deliveries that resulted in at least one live birth per embryo transfer.
Time frame: 40 weeks
Implantation rate
The percentage of gestational sacs observed divided by the number of embryos transferred
Time frame: 12 weeks
Pregnancy rate
The percentage of positive pregnancy test divided by the number of embryo transfers
Time frame: 20 weeks
Biochemical pregnancies
A pregnancy diagnosed only by the detection of beta hCG in serum
Time frame: 20 weeks
Ectopic pregnancies
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology
Time frame: 20 weeks
Clinical miscarriages
Spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age
Time frame: 20 weeks
Cumulative pregnancy rate
Cumulative pregnancy rate in the 12 months after the first study embryo transfer
Time frame: 12 months
Cumulative implantation rate
Cumulative implantation rate in the 12 months after the first study embryo transfer
Time frame: 12 months
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Porto Alegre, Rio Grande do Sul, Brazil
Centro de Reprodução Governador Mario Covas
São Paulo, Brazil
Sofia Hospital of Reproductive Medicine - SBALAGRM
Sofia, Bulgaria
Oak Clinic Sumiyoshi
Osaka, Japan
IVI Panama
Panama City, Panama
IVI Bilbao
Leioa, Bizkaia, Spain
IVI Madrid
Aravaca, Madrid, Spain
IVI Vigo
Vigo, Pontevedra, Spain
...and 6 more locations
Cumulative live birth delivery rate
Cumulative live birth delivery rate per embryo transfer in the 12 months after the first study embryo transfer
Time frame: 12 months