UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046909 |
|---|---|
| Receipt number | R000053483 |
| Scientific Title | Impact of chronic endometritis in endometrial receptivity and the prediction of the personalized window of implantation: a prospective before-and-after study |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2022/02/17 18:01:36 |
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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
| Obstetrics 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
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
inmaculada.moreno@igenomix.com
Sponsor or person
Institute
Igenomix Foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053483
