Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection

NCT05545995 — Unknown, 200 participants, Assisting Nature

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IVF Outcomes Based on Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection

RegistryNCT05545995
StatusUnknown
Study typeObservational
Enrollment200 (Estimated)
SponsorAssisting Nature (Other)
ConditionsInfertility, Aneuploidy, Chromosome Abnormality
Interventionsembryo selection (Other)
Datesstart 2022-10-01 (estimated), primary completion 2023-12-01 (estimated), completion 2024-03-01 (estimated), first posted 2022-09-19, last updated 2022-09-28
Locations1 site in Greece

Related Papers Related Patents Related Grants Related Experts
All trials for Infertility All trials for Aneuploidy All trials of embryo selection

-Summary

This is a prospective randomised study of the evaluation of the clinical IVF results after time lapse assisted embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.

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+Detailed description

A randomized prospective study focusing on subfertile women undergoing IVF treatment followed by embryo transfer on the blastocyst stage.

Women assigned to group A proceed to embryo transfer, after time lapse assisted embryo selection, while women of group B after non-invasive PGT-A assisted embryo selection.

IVF outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.

+Arms and interventions

ArmTypeInterventionsDescription
TIME LAPSEOther: embryo selectionWomen who proceed to embryo transfer after time lapse assisted embryo selection.
NI-PGT-AOther: embryo selectionWomen who proceed to embryo transfer after non-invasive PGT-A assisted embryo selection.
  • embryo selection (Other): The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A

+Outcome measures

Primary outcomes

  • Embryotransfers to conceive [Up to the embryotransfer of the last enrolled patient (Dec 2023)]: The number of the embryotransfers required for women to conceive
  • Time interval to conceive [Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)]: Time interval required for women to conceive (in months): from OPU day to positive hCG test
  • Cumulative Live Birth Rate [Up to 38 weeks after the embryo transfer]: Cumulative Live Birth Rate achieved after one OPU treatment

Secondary outcomes

  • Abortion rate [Up to 2nd trimester miscarriages]: The spontaneous miscarriage of women in both groups
  • DaC rate [Up to 24 weeks of pregnancy according to Greek Law]: The rate of the dilation and curretage rate in both groups

+Eligibility

Sex: Female, ages: 18 Years to 39 Years, accepts healthy volunteers

Inclusion Criteria:

* Women who followed IVF treatment
* 39 years old or younger
* Single embryo transfer
* blastocyst stage cultured embryos

Exclusion Criteria:

* women over the age of 39 years
* not blastocyst transfer (transfers performed at earlier embryo stage)
* double embryotransfer
* women who had invasive PGT-a test
* women whose embryos were not time-lapse monitored

+Locations (1)

FacilityCityCountryStatus
Assisting NatureThessalonikiGreeceRecruiting

+Investigators