TerminatedNot Applicable

RCT Study to Validate niPGT-A Clinical Benefit.

Stopped: The recruitment was halted on Mar 1st 2024, after the Data Monitoring Committee, due to low recruitment speed and sustained high dropout rate. Other elements impacted negatively, including the SARS-COV-2 pandemic or the inability to include new sites

Argentina, Brazil, France296 participantsStarted 2020-06-29

Plain-language summary

Chromosomal aneuploidies are linked with spontaneous miscarriages and abnormal offspring in human pregnancies. In addition, some types of aneuploidies are reported to prevent implantation. Thus, there is a need to identify the embryos with highest implantation potential on in vitro fertilization (IVF) programs. Since embryo morphology and kinetics have a weak association with embryo ploidy, trophectoderm biopsy plus Next-Generation Sequencing (NGS) is becoming a very popular approach to determine the embryo chromosomal status. This technique is called Preimplantation Genetic Testing for Aneuploidy (PGT-A). Although shown to be efficient, it is invasive for the embryo, requires specific technical skills and it remains expensive. Therefore, the development of a non-invasive, rapid and cheaper method for assessing embryo ploidy status would represent a progress in the field of IVF. The non-invasive approach has been explored by some groups that analyzed the Spent Blastocyst Medium (SBM) where the embryo was incubated up to the time of transfer or freezing. In daily routine, this media is discarded after finishing the culture of the embryo. Importantly, though, this media reportedly contains traces of embryonic cell-free DNA (cfDNA) that can represent the genetic load of the embryo. On the basis of that, the hypothesis of this study is that embryo prioritization according to the analysis of the embryonic cfDNA in the SBM could improve ongoing pregnancy rate in 10 percentual points compared to standard blastocyst transfer based on morphology.

Who can participate

Age range20 Years – 40 Years

SexFEMALE

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Inclusion Criteria: * Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved. * IVF patients intending to undergo deferred day 6/7 blastocyst SET for any medical indication. * All the oocytes/embryos from the cycle should follow the laboratory protocol described in the study (embryo culture and vitrification on day 6/7). * ICSI, IVF or ICSI/IVF performed in fresh own oocytes from couples not undergoing PGT-A. Note: Donor sperm is allowed. * Female age: 20-40 years, both included. Exclusion Criteria: * Assisted hatching and artificial collapse before collecting SBM samples. Note: Both procedures are allowed only after collecting the culture media sample. * A known abnormal karyotype if the couple provides it at consultation. If not, karyotype is not compulsory. * Couples planning to undergo PGT-M or PGT-SR cases will be excluded. * Surrogate pregnancy (in those countries where it is allowed). * ERA test and embryo transfer according to ERA result. * Time-lapse culture systems are not allowed after day 4 of culture. * Presence of pathologies or malformations that affect the uterine cavity such as polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx during the patient's participation in the study. Patients suffering these pathologies bef…

What they're measuring

Non-invasive analysis of the chromosomal status of the embryo

Timeframe: 7 days

Ongoing pregnancy rate

Timeframe: Over 12 weeks

Trial details

NCT IDNCT04000152

SponsorIgenomix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-18

View on ClinicalTrials.gov More Aneuploidy trials