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

NCT05547555 | Unknown DMC

• 1 other identifier: AN010
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Aneuploidy; Chromosome Abnormality

Keywords

IVF; PGT-A; NON- INVASIVE PGT-A; TIME LAPSE; EMBRYO SELECTION

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Abortion rate

  Up to 2nd trimester miscarriages

• DaC rate

  during pregnancy according to Greek Law

Study Arms (2)

INVASIVE PGT-A

Women who proceed to embryo transfer after invasive PGT-A embryo selection.

Diagnostic Test: embryo selection

NON INVASIVE PGT-A

Women who proceed to embryo transfer after non- invasive PGT-A embryo selection.

Diagnostic Test: embryo selection

Interventions

embryo selection DIAGNOSTIC_TEST

The basis of embryo selection for transfer: invasive PGT-A or after non-invasive PGT-A

INVASIVE PGT-A; NON INVASIVE PGT-A

Eligibility Criteria

• Age: 40 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Women who followed IVF treatment
• years old or older
• Single embryo transfer
• blastocyst stage cultured embryos

You may not qualify if:

• 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

Sponsors & Collaborators

• Assisting Nature: lead

Study Sites (1)

Assisting Nature

Thessaloniki, Thessaloniki, 57001, Greece

RECRUITING

MeSH Terms

Conditions

Infertility; Aneuploidy; Chromosome Aberrations

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Evangelos Papanikolaou, MD, PhD

CONTACT

00302310424294; drvagpapanikolaou@yahoo.gr

Maria Galiotou, MSc

CONTACT

00302310424294; galiotou@assistingnature.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

GR (1)