Endometrial Receptivity
Conditions
Keywords
Window of implantation, Personalized embryo transfer, Fresh embryo transfer, Delayed embryo transfer, Elective deferred embryo transfer, Endometrial receptivity array, Endometrial receptivity analysis, Endometrial receptivity test, Frozen embryo transfer
Brief summary
This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.
Detailed description
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.
Interventions
OTHERpersonalized Embryo Transfer (pET)
OTHERFrozen Embryo Transfer (FET)
OTHERFresh Embryo Transfer (ET)
Sponsors
Igenomix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
1. Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes. 2. Age ≤ 37 years 3. BMI: 18.5 to 30 4. Normal ovarian reserve (AFC ≥ 8; FSH \< 8) 5. The most appropriated stimulation protocol will be decided by their doctor. 6. Blastocyst transfer (on day 5 or 6) 7. Blastocyst vitrification with open protocols (Cryotop, Cryoleaf, or Cryolock) or closed protocols (Cryotip or CBSStraw.) 8. Any pathology affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx affecting the endometrial cavity must be previously operated.
Exclusion criteria
1. Patients with recurrent miscarriages (\> 2 previous biochemical pregnancies or \> 2 spontaneous miscarriages) 2. Patients with a severe male factor (spermatozoa \< 2 million/ml) 3. Patients with implantation failure (\>3 failed cycles with good quality embryos) Post-Randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth delivery rate | 40 weeks | Percentage of deliveries that resulted in at least one live birth per embryo transfer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 12 weeks | The percentage of gestational sacs observed divided by the number of embryos transferred |
| Pregnancy rate | 20 weeks | The percentage of positive pregnancy test divided by the number of embryo transfers |
| Biochemical pregnancies | 20 weeks | A pregnancy diagnosed only by the detection of beta hCG in serum |
| Cumulative live birth delivery rate | 12 months | Cumulative live birth delivery rate per embryo transfer in the 12 months after the first study embryo transfer |
| Clinical miscarriages | 20 weeks | Spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age |
| Cumulative pregnancy rate | 12 months | Cumulative pregnancy rate in the 12 months after the first study embryo transfer |
| Cumulative implantation rate | 12 months | Cumulative implantation rate in the 12 months after the first study embryo transfer |
| Ectopic pregnancies | 20 weeks | A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology |
Countries
Belgium, Brazil, Bulgaria, Japan, Panama, Spain, Turkey (Türkiye)
Outcome results
None listed