UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	carlos.gomez@igenomicx.com

Sponsor
Institute	Igenomix Headquarters, Parc Cientific. Univ. de Valencia
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025396