UMIN-CTR Clinical Trial

Basic information
Public title	Impact of chronic endometritis in endometrial receptivity and the prediction of the personalized window of implantation: a prospective before-and-after study
Acronym	Impact of chronic endometritis in the prediction of the personalized window of implantation: a prospective before-and-after study
Scientific Title	Impact of chronic endometritis in endometrial receptivity and the prediction of the personalized window of implantation: a prospective before-and-after study
Scientific Title:Acronym	Impact of chronic endometritis in the prediction of the personalized window of implantation: a prospective before-and-after study
Region	Japan Europe

Condition
Condition	Infertility
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To determine if the individualised WOI of patients diagnosed with CE changes after eliminating endometrial pathogens by antimicrobial therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Result of the ERA test
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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	Patients whose written informed consent approved by the Ethics Committee has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved. Infertile patients between 18-37 years old with positive diagnose of CE by EMMA test already performed in an HRT cycle (P+5 day,120+-3h of progesterone exposure). IVF patients with own oocytes aged 18-37 years old. BMI, 18.5 to 30.0 (both inclusive). Negative serological tests for HIV, HBV, HCV, RPR. Sperm concentration is more than 2 million sperm/ml
Key exclusion criteria	Patients who are IUD carriers in the 3 months prior to the first biopsy for EMMA test. Patients who have taken prescribed antibiotics in the last 3 months prior to the first biopsy for EMMA test. Cases where the patient has received previous prophylactic antibiotics (1 single dose) to ovarian puncture in the stimulation cycle may be accepted. The administration of this prophylactic antibiotic should be at least 1 month before the sample collection (first biopsy for the EMMA test). Patients that received any surgical procedure in the 3 months prior to the first biopsy for EMMA test. Patients that present a different endometrial preparation (HRT) for the different cycles included in the study (1st mock cycle, 2nd mock cycle, ET cycle) in terms of P4 dosage, timing or route of administration. Patients with endogenous P4 >1ng/mL determined at day P+0 of the HRT cycles included in the study (1st mock cycle, 2nd mock cycle, ET cycle) or with unknow levels of endogenous P4 before the administration exogenous progesterone in any of the HRT cycles included in the study. Patients receiving personalized ET with embryos other than blastocyst in days 5 or 6. Patients cured of CE that do not follow the recommendations of the 2nd ERA test for pET. And others.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Carlos Middle name Last name Simon
Organization	Igenomix Foundation
Division name	Igenomix Foundation
Zip code	46980 - Paterna
Address	Ronda Narcis Monturiol Estarriol, 11B, Parque Tecnologico de Paterna, Valencia, Spain
TEL	+34963905310
Email	carlos.simon@ivi.es

Public contact
Name of contact person	1st name Inmaculada Middle name Last name Moreno
Organization	Igenomix Foundation
Division name	Igenomix Foundation
Zip code	46980 - Paterna
Address	Ronda Narcis Monturiol Estarriol, 11B, Parque Tecnologico de Paterna, Valencia, Spain
TEL	+34963905310
Homepage URL
Email	inmaculada.moreno@igenomix.com

Sponsor
Institute	Igenomix Foundation
Institute
Department

Funding Source
Organization	Igenomix Foundation
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	JISART CRB
Address	5F, MF Sakurabashi Building, 2-6-23, Sonezakishinchi, Kita-ku, Osaka, Japan
Tel	0661319741
Email	N.A.

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 15 Day

Related information
URL releasing protocol
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	Open public recruiting
Date of protocol fixation	2021 Year 09 Month 28 Day
Date of IRB	2021 Year 12 Month 28 Day
Anticipated trial start date	2022 Year 02 Month 15 Day
Last follow-up date	2023 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	a prospective before-and-after study

Management information
Registered date	2022 Year 02 Month 14 Day
Last modified on	2022 Year 02 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053483