UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022044 |
|---|---|
| Receipt number | R000025396 |
| Scientific Title | Clinical Study, International, Multicentre, Prospective, Randomised, Interventional, and Controlled, Comparing Fresh Embryo Transfer (FET) Versus Elective Delayed Embryo Transfer (EDET), and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Array) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection) |
| Date of disclosure of the study information | 2016/04/28 |
| Last modified on | 2021/05/02 22:13:03 |
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Basic information
Public title
Clinical Study, International, Multicentre, Prospective, Randomised, Interventional, and Controlled, Comparing Fresh Embryo Transfer (FET) Versus Elective Delayed Embryo Transfer (EDET), and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Array) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)
Acronym
The ERA as a Diagnostic Guide for Personalised Embryo Transfer.
Scientific Title
Clinical Study, International, Multicentre, Prospective, Randomised, Interventional, and Controlled, Comparing Fresh Embryo Transfer (FET) Versus Elective Delayed Embryo Transfer (EDET), and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Array) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)
Scientific Title:Acronym
The ERA as a Diagnostic Guide for Personalised Embryo Transfer.
Region
| Japan | Asia(except Japan) | North America |
| South America | Europe |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Live Birth Rate between Fresh Embryo Transfer(FET) vs Elective Delayed Embryo Transfer (EDET) vs personalized Embryo Transfer (pET)
Key secondary outcomes
To investigate rates of: implantation, clinical pregnancy, biochemical pregnancy, spontaneous abortion, ectopic pregnancy, and obstetric pathologies.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Gene | Device,equipment | Maneuver |
| Other |
Interventions/Control_1
Arm A: 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).
Interventions/Control_2
Arm B: Deferred embryo transfer (DET)
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), an elective deferred embryo transfer (DET) will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage).
Interventions/Control_3
Arm C-R: pET (ERA)
Patients will undergo a cycle of endometrial preparation following hormone replacement therapy (HRT) and will undergo an endometrial biopsy in this substituted cycle after five days (around 120 hours) of progesterone administration. The ERA test will analyze the endometrial receptivity to determine the most suitable time (the most receptive stage) 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, if a receptive profile was previously demonstrated by the ERA test, a personalized embryo transfer (pET) will be performed following the same conditions in which the ERA test was obtained using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage).
Interventions/Control_4
Arm CNR: pET (ERA+ERA)
Patients will undergo a cycle of endometrial preparation following hormone replacement therapy (HRT) and will undergo an endometrial biopsy in this substituted cycle after five days (around 120 hours) of progesterone administration.The ERA test will analyze the endometrial receptivity to determine the most suitable time (the most receptive stage) for the embryo transfer. If the window of implantation (WOI) is displaced (profile non receptive), a new biopsy will be taken on a different day based on the result of the first ERA test to identify the personalized WOI. 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, a personalized embryo transfer (pET) will take place according to the second ERA test result. A pET using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage) will be performed following the same conditions as in the second ERA test.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 37 | years-old | >= |
Gender
Female
Key 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 appropriate 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.
Key exclusion criteria
1. Patients with repeated abortions (> 2 previous biochemical pregnancies or > 2 spontaneous abortions).
2. Patients with a severe male factor (spermatozoa < 2 million/ml).
3. Patients with implantation failure (>3 failed cycles with good quality embryos.
Target sample size
546
Research contact person
Name of lead principal investigator
| 1st name | Carlos |
| Middle name | |
| Last name | Simon |
Organization
Igenomix Headquarters, Parc Cientific.
Univ. de Valencia
Division name
Igenomix Headquarters, Parc Cientific. Univ. de Valencia
Zip code
46980 - Paterna
Address
Catedratico Agustin Escardino, 9 46980 Paterna-Valencia, Spain
TEL
+34963905310
carlos.simon@ivi.es
Public contact
Name of contact person
| 1st name | Carlos |
| Middle name | |
| Last name | Gomez |
Organization
Igenomix Headquarters, Parc Cientific. Univ. de Valencia
Division name
Igenomix Headquarters, Parc Cientific. Univ. de Valencia
Zip code
46980 - Paterna
Address
Catedratico Agustin Escardino, 9 46980 Paterna-Valencia, Spain
TEL
+34963905310
Homepage URL
carlos.gomez@igenomicx.com
Sponsor or person
Institute
Igenomix Headquarters, Parc Cientific. Univ. de Valencia
Institute
Department
Personal name
Funding Source
Organization
Igenomix Headquarters, Parc Cientific. Univ. de Valencia
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Spain
Other related organizations
Co-sponsor
Oak Clinic Sumiyoshi, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Igenomix Headquarters, Parc Cientific. Univ. de Valencia
Address
Catedratico Agustin Escardino,9 46980 Paterna-Valencia, Spain
Tel
+34963905310
carlos.gomez@igenomicx.com
Secondary IDs
Secondary IDs
YES
Study ID_1
1304-C-107-CS
Org. issuing International ID_1
Igenomix
Study ID_2
NCT01954758
Org. issuing International ID_2
ClinicalTrials.gov
IND to MHLW
Institutions
Institutions
Igenomix（スペイン）を中心に、スタンフォード大学（米国）、医療法人オーク会 オーク住吉産婦人科(大阪府）などの欧米諸国及びアジアの医療研究機関。
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 28 | Day |
Related information
URL releasing protocol
https://clinicaltrials.gov/show/NCT01954758
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025396
