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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06097559




Registration number
NCT06097559
Ethics application status
Date submitted
18/10/2023
Date registered
24/10/2023
Date last updated
31/12/2024

Titles & IDs
Public title
International Non-selection Study for ERA® Test in Patients with Previous Implantation Failures
Scientific title
A Multicenter, Prospective, Non-selection Study for Endometrial Receptivity Analysis Test in Patients with Previous Implantation Failures
Secondary ID [1] 0 0
IGX1-ENS-MR-22-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility of Uterine Origin 0 0
Implantation Failure 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Endometrial fluid and biopsy collection
Diagnosis / Prognosis - Endometrial fluid and biopsy collection

Clinical Outcomes in a Receptive Endometrium - Enrolled patients that according to the ERA® report are receptive.

The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid.

No drugs will be administered as per the study.

Clinical Outcomes in a Non-receptive Endometrium - Enrolled patients that according to the ERA® report have a displaced WOI and are non-receptive.

The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid.

No drugs will be administered as per the study.


Diagnosis / Prognosis: Endometrial fluid and biopsy collection
The ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration) in a HRT cycle, according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy.

Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice.

Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET.

Diagnosis / Prognosis: Endometrial fluid and biopsy collection
The ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration), according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy.

Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice.

Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET. In case of a non-receptive endometrium result, a second EB sample must be collected when indicated by the ERA report. Fluid sample collection will not be repeated in these cases.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Refinement of the ERA® computational analysis
Timepoint [1] 0 0
At least 12 gestational weeks
Secondary outcome [1] 0 0
Pregnancy rate (PR) in the FET
Timepoint [1] 0 0
2 weeks after the embryo transfer
Secondary outcome [2] 0 0
Implantation rate (IR) in the FET
Timepoint [2] 0 0
Up to 4 weeks after the embryo transfer
Secondary outcome [3] 0 0
Biochemical pregnancy rate (BPR) in the FET
Timepoint [3] 0 0
4 weeks after the embryo transfer
Secondary outcome [4] 0 0
Ectopic pregnancy rate (EPR) in the FET
Timepoint [4] 0 0
4-5 weeks after the embryo transfer
Secondary outcome [5] 0 0
Clinical miscarriage rate (CMR) in the FET
Timepoint [5] 0 0
Up to 22 gestational weeks
Secondary outcome [6] 0 0
Ongoing Pregnancy Rate (OPR) in the FET
Timepoint [6] 0 0
Over 12 gestational weeks
Secondary outcome [7] 0 0
Live Birth Delivery Rate (LBDR) in the FET
Timepoint [7] 0 0
40 gestational weeks
Secondary outcome [8] 0 0
Pregnancy rate (PR) in the pET
Timepoint [8] 0 0
2 weeks after the embryo transfer
Secondary outcome [9] 0 0
Implantation rate (IR) in the pET
Timepoint [9] 0 0
Up to 4 weeks after the embryo transfer
Secondary outcome [10] 0 0
Biochemical pregnancy rate (BPR) in the pET
Timepoint [10] 0 0
4 weeks after the embryo transfer
Secondary outcome [11] 0 0
Ectopic pregnancy rate (EPR) in the pET
Timepoint [11] 0 0
4-5 weeks after the embryo transfer
Secondary outcome [12] 0 0
Clinical miscarriage rate (CMR) in the pET
Timepoint [12] 0 0
Up to 22 gestational weeks
Secondary outcome [13] 0 0
Ongoing Pregnancy Rate (OPR) in the pET
Timepoint [13] 0 0
Over 12 gestational weeks
Secondary outcome [14] 0 0
Identification of new potential actionable biomarkers for endometrial receptivity
Timepoint [14] 0 0
1-2 months
Secondary outcome [15] 0 0
Clinical reproductive outcomes according to the microbiome profile by the EMMA® test
Timepoint [15] 0 0
Up to 40 gestational weeks
Secondary outcome [16] 0 0
Microbiome analysis concordance between endometrial fluid and biopsy
Timepoint [16] 0 0
1-2 months
Secondary outcome [17] 0 0
Determination of immune and metabolic changes related to endometrial receptivity
Timepoint [17] 0 0
1-2 months
Secondary outcome [18] 0 0
Cost-effectiveness of OP per patient
Timepoint [18] 0 0
At least 12 gestational weeks

Eligibility
Key inclusion criteria
* Study ICF signature.
* Female age between 18 and 41 years (both included).
* IVF/ICSI (own or donated gametes) patients with =1 previous failed euploid/low-range mosaic embryo transfer(s) or =2 previous failed transfers with non-tested good quality embryos. (ROPA method is allowed).
* =1 PGT-A tested euploid/low-range mosaic blastocyst (day 5/6) available to be transferred (SET or DET according to medical recommendation).
* BMI 18.0 - 30.0 Kg/m2.
* Negative serological tests for HIV, HBV, HCV, RPR.
Minimum age
18 Years
Maximum age
41 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* No HRT in the biopsy and/or the embryo transfer cycle.
* Intrauterine device (IUD) carriers within 3 months before sample collection.
* Surrogate pregnancy (in those countries where it is allowed).
* Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas > 4 cm, or hydrosalpinx. (Note: Patients are allowed to participate if the pathology is previously operated at least 3 months before the endometrial samples are obtained).
* Recurrent Pregnancy Loss (RPL =2 previous intrauterine miscarriages).
* Active endometritis and salpingitis at the moment of the inclusion.
* Endometriosis stage > I (stages II, III and IV) according to ASRM classification.
* Atrophic endometrium (< 6 mm) in the ERA® and/or embryo transfer cycle.
* Endometrial receptivity test and/or microbiome test done before ICF signature.
* Preimplantation Genetic Testing for Chromosomal Structural Rearrangements (PGT-SR) or Preimplantation Genetic Testing for Monogenic Disorders (PGT-M) concomitant indications.
* DuoStim IVF protocol (double ovarian stimulation and two egg retrievals in the same ovarian cycle).
* Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
738
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Number 1 Fertility - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Brazil
State/province [3] 0 0
Porto Alegre
Country [4] 0 0
Panama
State/province [4] 0 0
Panama City
Country [5] 0 0
Peru
State/province [5] 0 0
Lima
Country [6] 0 0
Spain
State/province [6] 0 0
Málaga
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Spain
State/province [8] 0 0
Sevilla
Country [9] 0 0
Spain
State/province [9] 0 0
Valladolid
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Igenomix
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Women´s period comprises different hormonal stages, being one of them the stage for maximum receptivity and proper embryo implantation. This stage is named window of implantation (WOI), and is characterized by a specific molecular pattern than can be assessed by the Endometrial Receptivity Analysis (ERA® test), developed by Igenomix. Determining the WOI allows to schedule a personalized embryo transfer (pET) when the endometrium is most receptive for the implantation.

The main objective of the present study is to improve our knowledge on the endometrial factor in an infertile population with previous implantation failures. To do so, a diagnosis of the endometrial receptivity to determine the WOI (ERA®) and the microbiome (EMMA®) of each participant will be performed, assessing its impact on deferred embryo transfers in terms of reproductive outcomes.

Participants will follow their previously programmed IVF/ICSI treatment and, only when one embryo with no major anomalies is reported by PGT-A (Preimplantation Genetic Testing for Aneuploidies), they will be asked to attend to the specific study visit for endometrial fluid and biopsy samples collection. These samples will be used to determine the patient's WOI (ERA®) and endometrial microbiome (EMMA®). The results of neither of the tests will be disclosed to the patient or the doctor, being only used for the study purpose. After this visit, the patient will follow the pre-established schedule for an embryo transfer and pregnancy assessment.
Trial website
https://clinicaltrials.gov/study/NCT06097559
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maria Ruiz, MSc
Address 0 0
Igenomix
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carlos Gomez, BSc MSc
Address 0 0
Country 0 0
Phone 0 0
+34963905310
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06097559