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

• Sponsor: Assisting Nature (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05545995
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 11.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility; Aneuploidy; Chromosome Abnormality	Other: 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 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: IVF Outcomes Based on Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
TIME LAPSE Women who proceed to embryo transfer after time lapse assisted embryo selection.	Other: embryo selection; The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A
NI-PGT-A Women who proceed to embryo transfer after non-invasive PGT-A assisted embryo selection.	Other: embryo selection; The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A

Outcome Measures

Primary Outcome Measures

1. Embryotransfers to conceive [Up to the embryotransfer of the last enrolled patient (Dec 2023)]

   The number of the embryotransfers required for women to conceive

2. Time interval to conceive [Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)]

   Time interval required for women to conceive (in months): from OPU day to positive hCG test

3. Cumulative Live Birth Rate [Up to 38 weeks after the embryo transfer]

   Cumulative Live Birth Rate achieved after one OPU treatment

Secondary Outcome Measures

1. Abortion rate [Up to 2nd trimester miscarriages]

   The spontaneous miscarriage of women in both groups

2. DaC rate [Up to 24 weeks of pregnancy according to Greek Law]

   The rate of the dilation and curretage rate in both groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assisting Nature	Thessaloníki		Greece	57001

Sponsors and Collaborators

• Assisting Nature

Investigators

• Principal Investigator: Evangelos Papanikolaou, MD,PhD, Assisting Nature

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Papanikolaou Evaggelos, Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic, Assisting Nature
• ClinicalTrials.gov Identifier: NCT05545995
• Other Study ID Numbers: AN009
• First Posted: Sep 19, 2022
• Last Update Posted: Sep 28, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Papanikolaou Evaggelos, Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic, Assisting Nature: IVF; PGT-A; NON- INVASIVE PGT-A; TIME LAPSE; EMBRYO SELECTION
• Additional relevant MeSH terms: Infertility; Chromosome Disorders; Aneuploidy; Chromosome Aberrations

Study Results

No Results Posted as of Sep 28, 2022