Status:
ACTIVE_NOT_RECRUITING
International Non-selection Study for ERA® Test in Patients With Previous Implantation Failures
Lead Sponsor:
Igenomix
Conditions:
Infertility of Uterine Origin
Implantation Failure
Eligibility:
FEMALE
18-41 years
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 charact...
Detailed Description
Endometrial receptivity takes place in a self-limited period of time during the endometrial mid-secretory stage. This period, named as window of implantation (WOI), is modulated by molecular changes a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
738 Patients enrolled
Trial Details
Trial ID
NCT06097559
Start Date
January 16 2024
End Date
December 1 2026
Last Update
August 5 2025
Active Locations (8)
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1
In Vitro Buenos Aires
Buenos Aires, Buenos Aires, Argentina, C1058 AAL
2
The Fertile Group
Panama City, Panama
3
Inmater
San Borja, Lima region, Peru, 15036
4
Ovoclinic Madrid
Madrid, Madrid, Spain, 28035