International Pilot Study for Dual Non-invasive Assesment of Embryo Development

Launched by IGENOMIX · Jul 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to assess embryo development during in vitro fertilization (IVF) to help choose the best embryos for implantation. The study is combining two non-invasive techniques that do not require any manipulation of the embryos, aiming to see if certain growth patterns can provide insights into the embryos' chromosomal health. Women who are planning to undergo IVF with a specific type of genetic testing called niPGT-A may be invited to participate in this study.

To be eligible, participants need to be women aged between 20 and 42 who are undergoing IVF treatment with their own or donated eggs. They should also be using embryos that will be tested for genetic health before being transferred back into the uterus. If you decide to participate, you will follow your planned IVF treatment without any extra appointments, and your embryos will be monitored in a special time-lapse system. After the embryos are evaluated, the best ones will be chosen for transfer based on the usual medical practices. Your follow-up care will continue as normal after the transfer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.