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

NCT05545995 | Unknown DMC

• 1 other identifier: AN009
• 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 time lapse assisted 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 OPU day 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

  Up to 24 weeks of pregnancy according to Greek Law

Study Arms (2)

TIME LAPSE

Women who proceed to embryo transfer after time lapse assisted embryo selection.

Other: embryo selection

NI-PGT-A

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

Other: embryo selection

Interventions

embryo selection OTHER

The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A

NI-PGT-A; TIME LAPSE

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assisting Nature: lead

Study Sites (1)

Assisting Nature

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

Study Officials

• Evangelos Papanikolaou, MD,PhD

  Assisting Nature

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)