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

Recruiting

• Conditions: Aneuploidy; Infertility; Chromosome Abnormality
• Interventions: Other: embryo selection

• Registration Number: NCT05545995
• Lead Sponsor: Assisting Nature

Brief 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.

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-19
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28
• 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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TIME LAPSE	embryo selection	Women who proceed to embryo transfer after time lapse assisted embryo selection.
NI-PGT-A	embryo selection	Women who proceed to embryo transfer after non-invasive PGT-A assisted embryo selection.

Primary Outcome Measures

Name	Time	Method
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
Embryotransfers to conceive	Up to the embryotransfer of the last enrolled patient (Dec 2023)	The number of the embryotransfers required for women to conceive

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Assisting Nature; 🇬🇷 Thessaloníki, Greece