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Prospective Observational Study of the Morphokinetics and Ploidy of Blastocysts With Abnormal Fertilization (1PN, 2.1PN and 3PN) to Identify the Origin of Fertilization Alterations

Status: Recruiting
Location: See location...
Intervention Type: Genetic, Diagnostic test
Study Type: Observational
SUMMARY

The goal of this observational study is to determine the diploidy rate of haploid and triploid embryos from in vitro fertilization (IVF) cycles. The main questions it aims to answer are: * Can a molecular genetic fertilization check of abnormally fertilized embryos be used to expand opportunities for couples undergoing assisted reproduction treatment? * Is the chromosomal loss or gain present in abnormally fertilized embryos predominantly maternal in origin? For this purpose, we will evaluate the morphokinetics and ploidy of about 300 embryos with different types of abnormal pronuclear patterns (1PN, 2.1PN, and 3PN) that reach the blastocyst stage. Whenever possible, embryos with a non-diploid chromosomal complement will also be assessed to determine the origin (maternal or paternal) of the chromosomal set that has been lost or gained. Study subjects will follow their previously scheduIed IVF/ICSI treatment and no additional visits/interventions will be required for participating.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• ART patients who sign the Informed Consent of the study.

• Age: oocytes from women ≤ 49 years and semen from men ≤ 60 years. Donation of gametes is allowed.

• ≥1 blastocysts from oocytes with an abnormal pronuclear pattern (1PN, 2.1PN, and/or 3PN) and with the presence of 2 polar bodies (PB), cultured in a time-lapse incubator.

Locations
Other Locations
Spain
Equipo Médico Crespo Valencia
RECRUITING
Valencia
Contact Information
Primary
Carlos A Gomez De La Cruz, BSc MSc
carlos.gomez@igenomix.com
+34963905310
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 300
Treatments
Blastocysts from abnormally fertilized oocytes during assisted reproduction
During the conventional ICSI/IVF procedures in the laboratory, the embryologist observing fertilization will identify embryos with an abnormal pronuclear pattern and preselect them for the study. These embryos will be cultured in a time-lapse incubator following the laboratory's standard practice. All recorded morphokinetic parameters, along with the corresponding images, will be documented. Each embryo will be monitored, its developmental quality assessed and recorded to determine whether it reaches the blastocyst stage. If so, the researchers will contact the patient to ask consent for these embryos to be included in the study.~Embryos with an abnormal pronuclear pattern that fail to reach the blastocyst stage due to developmental blockage will be discarded.~No drugs or medical devices will be used.
Related Therapeutic Areas
Sponsors
Leads: Igenomix

This content was sourced from clinicaltrials.gov