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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547555
• Other study ID #: AN010
• Status: Recruiting
• Start date: October 2022
• Est. completion date: March 2024

Study information

• Verified date: September 2022
• Source: Assisting Nature
• Contact: Evangelos Papanikolaou, MD, PhD
• Phone: 00302310424294
• Email: drvagpapanikolaou[@]yahoo.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Chromosome Aberrations
• Chromosome Abnormality
• Chromosome Disorders
• Infertility

Intervention

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

Locations

Country	Name	City	State
Greece	Assisting Nature	Thessaloníki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Assisting Nature

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryotransfers to conceive	The number of the embryotransfers required for women to conceive	Up to the embryotransfer of the last enrolled patient (Dec 2023)
Primary	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)
Primary	Cumulative Live Birth Rate	Cumulative Live Birth Rate achieved after one OPU treatment	Up to 38 weeks after the embryo transfer
Secondary	Abortion rate	The spontaneous miscarriage of women in both groups	Up to 2nd trimester miscarriages
Secondary	DaC rate	The rate of the dilation and curretage rate in both groups	during pregnancy according to Greek Law