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

Recruiting

• Conditions: Aneuploidy; Infertility; Chromosome Abnormality
• Interventions: Diagnostic Test: embryo selection

• Registration Number: NCT05547555
• Lead Sponsor: Assisting Nature

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.

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 Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21
• Study Start: 2022-10
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
INVASIVE PGT-A	embryo selection	Women who proceed to embryo transfer after invasive PGT-A embryo selection.
NON INVASIVE PGT-A	embryo selection	Women who proceed to embryo transfer after non- invasive PGT-A embryo selection.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Assisting Nature; 🇬🇷 Thessaloníki, Thessaloniki, Greece