Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT06097559
Eligibility Criteria:
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.
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
41 Years
Study:
NCT06097559
Study Brief:
Protocol Section:
NCT06097559