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

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

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.

Study Overview

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

Contacts and Locations

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 54 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women 40 years old or older who were divided in two groups according to the embryo selection criteria for embryotransfer: women in group A proceeded to embryo transfer after invasive PGT-A assisted embryo selection and women in group B proceeded to embryo transfer after non- invasive PGT-A assisted embryo selection.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

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)
Time interval to conceive	Time interval required for women to conceive (in months): from day of first embryotransfer to positive hCG test	Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)
Cumulative Live Birth Rate	Cumulative Live Birth Rate achieved after one OPU treatment	Up to 38 weeks after the embryo transfer

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	during pregnancy according to Greek Law

Collaborators and Investigators

• Sponsor: 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 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (ACTUAL): September 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 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: AN010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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