Clinical trial NCT01954758: The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer
Official title: Clinical Study, International, Multicentre, Prospective, Randomised, Interventional and Controlled, Comparing Fresh Embryo Transfer (ET) Versus Frozen Embryo Transfer (FET) and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Analysis) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Receptivity
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
Lead sponsor: Igenomix
Sponsor class: INDUSTRY
First posted: 2013-10-07
Enrollment: 569
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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 Exclusion Criteria:

1. Endogenous progesterone level ≥ 1,5 ng/ml at the day of hCG administration in all groups.
2. Absence of blastocysts (day 5 or 6) for embryo transfer.
3. Risk of ovarian hyperstimulation syndrome in any of the three groups and therefore a clinical indication to cancel the transfer cycle where the stimulated patient is from group A (ET).

Note: PGT-A is not an inclusion criteria neither an exclusion criteria, therefore those cycles in which PGT-A was performed will be included

Primary outcomes:
measure: Live birth delivery rate
timeFrame: 40 weeks
Secondary outcomes:
measure: Implantation rate
timeFrame: 12 weeks
measure: Pregnancy rate
timeFrame: 20 weeks
measure: Biochemical pregnancies
timeFrame: 20 weeks
measure: Ectopic pregnancies
timeFrame: 20 weeks
measure: Clinical miscarriages
timeFrame: 20 weeks
measure: Cumulative pregnancy rate
timeFrame: 12 months
measure: Cumulative implantation rate
timeFrame: 12 months
measure: Cumulative live birth delivery rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre of Reproductive Medicine UZ Brussles
city: Campos dos Goytacazes
country: Brazil
facility: Centro de Infertilidade e Medicina Fetal do Norte Fluminence
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Centro de Reproduçao Humana Nilo Frantz
state: Rio Grande Del Sur
city: Sao Paulo
country: Brazil
facility: Centro de Reprodução Governador Mario Covas
city: Sofia
country: Bulgaria
facility: Sofia Hospital of Reproductive Medicine - SBALAGRM
city: Osaka
country: Japan
facility: Oak Clinic Sumiyoshi
city: Panama
country: Panama
facility: IVI Panama
city: Leioa
country: Spain
facility: IVI Bilbao
state: Bizkaia
city: Aravaca
country: Spain
facility: IVI Madrid
state: Madrid
city: Vigo
country: Spain
facility: IVI Vigo
state: Pontevedra
city: Alicante
country: Spain
facility: IVI Alicante
city: Barcelona
country: Spain
facility: IVI Barcelona
city: Madrid
country: Spain
facility: ProcreaTec
city: Sevilla
country: Spain
facility: IVI Sevilla
city: Valencia
country: Spain
facility: IVI Valencia
city: Istanbul
country: Turkey
facility: Bahceci Health Group
Study officials:
affiliation: IVI Valencia / Igenomix
name: Carlos Simon, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katzorke N, Vilella F, Ruiz M, Krussel JS, Simon C. Diagnosis of Endometrial-Factor Infertility: Current Approaches and New Avenues for Research. Geburtshilfe Frauenheilkd. 2016 Jun;76(6):699-703. doi: 10.1055/s-0042-103752.