Health TrialsbyHealthPanel

Study of Abnormally Fertilized Embryos

ConditionInfertility (IVF Patients)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-49
SponsorIgenomix

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

No exclusion criteria have been considered for this study.

Trial population

Embryos from subjects undergoing assisted reproductive treatment with oocytes exhibiting an abnormal number of pronuclei (1PN, 2.1PN, and/or 3PN). Recruitment of subjects for the study will be conducted through routine consultation with the principal investigator and collaborators, as long as they meet the selection criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Parental samples

    Genetic

    On fertilization, following the conventional ICSI/IVF procedure, samples from cumulus cells (obtained during the routine oocyte denudation process) and surplus sperm cells present in seminal plasma will be retrieved. These samples will be stored frozen at -20°C until they are sent to Igenomix. There, they will be used to perform the genetic analysis required to achieve the study's objectives, provided the patient consents to participate. If the patient ultimately chooses not to participate, these samples will be destroyed. Parents may be asked to provide a saliva sample for the same purpose in cases where obtaining the samples during fertilization was not possible or if the collected samples were unsuitable for processing in the laboratory. The saliva sample may be collected at the clinic during one of the scheduled visits for reproductive treatment or, alternatively, by the parents at home using a kit provided by the clinic.

  • PGT-A

    Diagnostic test

    On day 3 of development, assisted hatching will be performed to facilitate biopsy at the blastocyst stage. Each embryo will be biopsied in the laboratory using conventional trophectoderm (TE) biopsy techniques on day +5, +6, or +7 of development, depending on when they reach the appropriate blastocyst stage. After biopsy, blastocyst will be vitrified following the clinical routine protocol and store until the genetic results are available. The biopsy samples will be placed in a PCR tube labeled with its corresponding study-specific code and stored in a cold rack at 4°C before being transferred to a freezer at -20°C. Finally, the samples will be sent to the Igenomix for preimplantation genetic testing for aneuploidy.

  • TE rebiopsies and spent blastocyst media collection

    Genetic

    After obtaining the PGT-A results, any embryo not genetically confirmed as euploid and without ploidy abnormalities will be thawed, washed, and cultured for rebiopsy. A complementary analysis using next-generation sequencing (NGS) techniques will be performed to confirm the diagnosis and determine the origin of the abnormalities. For this additional analysis, in addition to the new biopsies, the individual culture medium of each embryo will be aspirated after an incubation period of 8 to 24 hours. The collected medium will be placed in PCR tubes and stored in a freezer at -20°C before being sent to the laboratory. Regardless the result of these complementary analysis, no rebiopsied blastocyst will be considered for clinical purposes.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Blastocysts from abnormally fertilized oocytes during assisted reproduction3 interventions

Trial outcomes

Primary outcomes

1

Diploidy rate in haploid embryos from IVF/ICSI

Number of 2PN blastocysts from abnormally fertilized oocytes (1PN)

Time frame
3 months
2

Diploidy rate in triploid embryos from IVF/ICSI

Number of 2PN blastocysts from abnormally fertilized oocytes (2.1PN and 3PN)

Time frame
3 months

Secondary outcomes

1

Origin of the chromosomal abnormalities in embryos with a non-diploid chromosomal content

To determine the origin (maternal or paternal) of the chromosomal set that has been lost or gained.

Time frame
6 months
2

Pregnancy rate of euploid embryos from abnormal fertilization

Number of patients with positive serum level of β-human chorionic gonadotropin (βhCG \> 25 mIU/ml) per embryo transfer. Beta-hCG will be measured at day 12±2 after the embryo transfer.

Time frame
2 weeks after the embryo transfer
3

Implantation rate of euploid embryos from abnormal fertilization

Number of gestational sacs observed by vaginal ultrasound divided by the number of embryos transferred.

Time frame
Up to 4 weeks after the embryo transfer
4

Biochemical pregnancy rate of euploid embryos from abnormal fertilization

Number of pregnancies diagnosed only by β-hCG detection without a gestational sac visualized by vaginal ultrasound, per number of pregnancies.

Time frame
4 weeks after the embryo transfer with euploid embryos from abnormal fertilization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Igenomix

Lead sponsor

Source ClinicalTrials.gov
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