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

Sponsor

Assisting Nature (Other)

Overall Status

Recruiting

CT.gov ID

NCT05547555

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility Aneuploidy Chromosome Abnormality	Diagnostic Test: embryo selection

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 invasive PGT-A 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
INVASIVE PGT-A Women who proceed to embryo transfer after invasive PGT-A embryo selection.	Diagnostic Test: embryo selection The basis of embryo selection for transfer: invasive PGT-A or after non-invasive PGT-A
NON INVASIVE PGT-A Women who proceed to embryo transfer after non- invasive PGT-A embryo selection.	Diagnostic Test: embryo selection The basis of embryo selection for transfer: invasive PGT-A or after non-invasive PGT-A

Arm

Intervention/Treatment

INVASIVE PGT-A

Women who proceed to embryo transfer after invasive PGT-A embryo selection.

Diagnostic Test: embryo selection

The basis of embryo selection for transfer: invasive PGT-A or after non-invasive PGT-A

NON INVASIVE PGT-A

Women who proceed to embryo transfer after non- invasive PGT-A embryo selection.

Diagnostic Test: embryo selection

The basis of embryo selection for transfer: invasive PGT-A or after non-invasive PGT-A

Outcome Measures

Primary Outcome Measures

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 day of first embryotransfer 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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 54 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women who followed IVF treatment
40 years old or older
Single embryo transfer
blastocyst stage cultured embryos

Exclusion Criteria:

women under the age of 40 years
not blastocyst transfer (transfers performed at earlier embryo stage)
double embryotransfer
women who had embryotransfer according to morphological criteria women whose embryos were not time-lapse monitored