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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05545995
Other study ID # AN009
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
Study type Observational

Clinical Trial 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.


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.


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 18 Years to 39 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Greece Assisting Nature Thessaloníki

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 OPU day 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 Up to 24 weeks of pregnancy according to Greek Law
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