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Clinical Trials/NCT05545995
NCT05545995
Recruiting
Not Applicable

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

Assisting Nature1 site in 1 country200 target enrollmentOctober 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aneuploidy
Sponsor
Assisting Nature
Enrollment
200
Locations
1
Primary Endpoint
Time interval to conceive
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2022
End Date
March 2024
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Assisting Nature
Responsible Party
Principal Investigator
Principal Investigator

Papanikolaou Evaggelos

Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic

Assisting Nature

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time interval to conceive

Time Frame: 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

Time Frame: Up to 38 weeks after the embryo transfer

Cumulative Live Birth Rate achieved after one OPU treatment

Embryotransfers to conceive

Time Frame: Up to the embryotransfer of the last enrolled patient (Dec 2023)

The number of the embryotransfers required for women to conceive

Secondary Outcomes

  • Abortion rate(Up to 2nd trimester miscarriages)
  • DaC rate(Up to 24 weeks of pregnancy according to Greek Law)

Study Sites (1)

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