Status:
RECRUITING
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Lead Sponsor:
Igenomix
Conditions:
Infertility
Eligibility:
FEMALE
20-42 years
Brief Summary
Choosing the best embryo is one of the major challenges for achieving success in in vitro fertilization (IVF). Traditionally, embryo evaluation has been based on morphological quality (how the embryo ...
Detailed Description
Embryo selection represents one of the major challenges for achieving success in in vitro fertilization (IVF) cycles. Traditionally, embryo evaluation has been based on morphological quality and chrom...
Eligibility Criteria
Inclusion
- Study ICF signature.
- Female age between 20 and 42 years (bot included).
- IVF, ICSI or IVF/ICSI performed in fresh own or donated oocytes. Note: donor sperm is allowed.
- niPGT-A cases with a deferred SET (of a day 6/7 vitrified blastocyst) for any medical indication.
- Embryos cultured individually in a TL system from day 0/1 to day 6/7.
Exclusion
- Embryos with abnormal fertilization (different from 2PN). (Note: In case of no 2PN embryos, patients may repeat the COS cycle).
- Female/couple with PGT-M and/or PGT-SR indication.
- Assisted hatching and/or artificial collapse before media collection.
- Known abnormal karyotype.
- Pathologies or malformations affecting the uterine cavity (polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx) during the patient's participation. (Note: patients are allowed to participate if the pathology is previously operated at least 3 months before patient enrollment).
- 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 :
October 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06524648
Start Date
October 29 2024
End Date
January 1 2027
Last Update
August 1 2025
Active Locations (8)
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1
Kinderwunsch Institut Schenk
Dobl, Austria, A-8143
2
Fertty
Barcelona, Barcelona, Spain, 08010
3
Hospital Ruber Internacional
Madrid, Madrid, Spain, 28034
4
Next Fertility Murcia
Murcia, Murcia, Spain, 30007