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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; Aneuploidy; Chromosome Abnormality
• Intervention / Treatment: Other: 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 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Maria Galiotou, MSc; Phone Number: 00302310424294; Email: galiotou@assistingnature.gr
• Study Contact Backup: Name: Evangelos Papanikolaou, MD,PhD; Phone Number: 00302310424294; Email: drvagpapanikolaou@yahoo.gr

Study Locations

• Greece
  • Thessaloníki, Greece, 57001
    • Recruiting
    • Assisting Nature
    • Contact: Maria Galiotou, MSc; Phone Number: 00302310424294; Email: galiotou@assistingnature.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women aged 18- 39, faced with infertility issues, meeting the above inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TIME LAPSE; Women who proceed to embryo transfer after time lapse assisted embryo selection.	Other: embryo selection; The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A
NI-PGT-A; Women who proceed to embryo transfer after non-invasive PGT-A assisted embryo selection.	Other: embryo selection; The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abortion rate	The spontaneous miscarriage of women in both groups	Up to 2nd trimester miscarriages
DaC rate	The rate of the dilation and curretage rate in both groups	Up to 24 weeks of pregnancy according to Greek Law

Collaborators and Investigators

• Sponsor: Assisting Nature
• Investigators: Principal Investigator: Evangelos Papanikolaou, MD,PhD, Assisting Nature

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (ACTUAL): September 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: IVF; PGT-A; NON- INVASIVE PGT-A; TIME LAPSE; EMBRYO SELECTION
• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Genetic Diseases, Inborn; Infertility; Aneuploidy; Chromosome Disorders; Chromosome Aberrations
• Other Study ID Numbers: AN009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No