The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer
NCT ID: NCT01954758
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
569 participants
INTERVENTIONAL
2013-11-25
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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)
personalized Embryo Transfer (pET)
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).
Frozen Embryo Transfer (FET)
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).
Fresh Embryo Transfer (ET)
Interventions
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personalized Embryo Transfer (pET)
Frozen Embryo Transfer (FET)
Fresh Embryo Transfer (ET)
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with a severe male factor (spermatozoa \< 2 million/ml)
3. Patients with implantation failure (\>3 failed cycles with good quality embryos)
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).
18 Years
37 Years
FEMALE
No
Sponsors
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Igenomix
INDUSTRY
Responsible Party
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Carlos Simon
Scientific Director IGENOMIX; Gynaecologist IVI Valencia
Principal Investigators
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Carlos Simon, MDPhD
Role: PRINCIPAL_INVESTIGATOR
IVI Valencia / Igenomix
Locations
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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
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
IVI Alicante
Alicante, , Spain
IVI Barcelona
Barcelona, , Spain
ProcreaTec
Madrid, , Spain
IVI Sevilla
Seville, , Spain
IVI Valencia
Valencia, , Spain
Bahceci Health Group
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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1304-C-107-CS
Identifier Type: -
Identifier Source: org_study_id
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