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The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer (ERA RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01954758
Recruitment Status : Completed
First Posted : October 7, 2013
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary:
This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.

Condition or disease Intervention/treatment Phase
Endometrial Receptivity Other: personalized Embryo Transfer (pET) Other: Frozen Embryo Transfer (FET) Other: Fresh Embryo Transfer (ET) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 569 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : November 25, 2013
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Arm Intervention/treatment
Experimental: Personalized embryo transfer (pET)
Patients will undergo a cycle of endometrial preparation following hormone replacement therapy (HRT) and an endometrial biopsy in a substituted cycle after 5 days (around 120 hours) of progesterone administration. The ERA test will determine the window of implantation (WOI) for each patient and will recommend the best time for embryo transfer thereby increasing the chances of a successful outcome. In some specific cases (≤ 10%) a second biopsy will be required to help the bioinformatic predictor to ensure the most appropriated moment for the embryo transfer. In a different cycle, patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI and vitrified. In a subsequent cycle, following the ERA result, a personalized embryo transfer (pET) will be carried out following the same conditions in which the ERA test was obtained, using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage)
Other: personalized Embryo Transfer (pET)
Active Comparator: Frozen embryo transfer (FET)
Patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In a subsequent cycle, following hormone replacement therapy (HRT), a frozen embryo transfer (FET) will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage).
Other: Frozen Embryo Transfer (FET)
Active Comparator: Fresh embryo transfer (ET)
Patients will undergo a controlled ovarian stimulation cycle (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In the same cycle, a fresh embryo transfer will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage).
Other: Fresh Embryo Transfer (ET)



Primary Outcome Measures :
  1. Live birth delivery rate [ Time Frame: 40 weeks ]
    Percentage of deliveries that resulted in at least one live birth per embryo transfer.


Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: 12 weeks ]
    The percentage of gestational sacs observed divided by the number of embryos transferred

  2. Pregnancy rate [ Time Frame: 20 weeks ]
    The percentage of positive pregnancy test divided by the number of embryo transfers

  3. Biochemical pregnancies [ Time Frame: 20 weeks ]
    A pregnancy diagnosed only by the detection of beta hCG in serum

  4. Ectopic pregnancies [ Time Frame: 20 weeks ]
    A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology

  5. Clinical miscarriages [ Time Frame: 20 weeks ]
    Spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age

  6. Cumulative pregnancy rate [ Time Frame: 12 months ]
    Cumulative pregnancy rate in the 12 months after the first study embryo transfer

  7. Cumulative implantation rate [ Time Frame: 12 months ]
    Cumulative implantation rate in the 12 months after the first study embryo transfer

  8. Cumulative live birth delivery rate [ Time Frame: 12 months ]
    Cumulative live birth delivery rate per embryo transfer in the 12 months after the first study embryo transfer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women undergoing IVF treatment
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954758


Locations
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Belgium
Centre of Reproductive Medicine UZ Brussles
Brussels, Belgium, 1090
Brazil
Centro de Infertilidade e Medicina Fetal do Norte Fluminence
Campos dos Goytacazes, Rio De Janeiro, Brazil, 28035-210
Centro de Reproduçao Humana Nilo Frantz
Porto Alegre, Rio Grande Del Sur, Brazil
Centro de Reprodução Governador Mario Covas
Sao Paulo, Brazil
Bulgaria
Sofia Hospital of Reproductive Medicine - SBALAGRM
Sofia, Bulgaria, 1000
Japan
Oak Clinic Sumiyoshi
Osaka, Japan, 557-0045
Panama
IVI Panama
Panama, Panama, 0819
Spain
IVI Bilbao
Leioa, Bizkaia, Spain, 48940
IVI Madrid
Aravaca, Madrid, Spain, 24527
IVI Vigo
Vigo, Pontevedra, Spain, 36203
IVI Alicante
Alicante, Spain, 03015
IVI Barcelona
Barcelona, Spain, 08017
ProcreaTec
Madrid, Spain, 28036
IVI Sevilla
Sevilla, Spain, 41011
IVI Valencia
Valencia, Spain, 46015
Turkey
Bahceci Health Group
Istanbul, Turkey, 34500
Sponsors and Collaborators
Igenomix
Investigators
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Principal Investigator: Carlos Simon, MDPhD IVI Valencia / Igenomix

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carlos Simon, Scientific Director IGENOMIX; Gynaecologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01954758    
Other Study ID Numbers: 1304-C-107-CS
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA:
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