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Status unknownNCT05547555Updated Sep 21, 2022

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

An observational study in Infertility, Aneuploidy and Chromosome Abnormality, sponsored by Assisting Nature. Status unknown at 1 site in Greece. Open to female participants aged 40 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Assisting Nature · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
40 Years to 54 Years
Sex
Female
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Infertility
  • Aneuploidy
  • Chromosome Abnormality

Keywords

  • IVF
  • PGT-A
  • NON- INVASIVE PGT-A
  • TIME LAPSE
  • EMBRYO SELECTION
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 592 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Assisting Nature is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 54 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testembryo selection

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

06

What researchers measure

Primary outcomes

  1. Embryotransfers to conceive

    The number of the embryotransfers required for women to conceive

    Time frame: Up to the embryotransfer of the last enrolled patient (Dec 2023)

  2. Time interval to conceive

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

    Time frame: Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)

  3. Cumulative Live Birth Rate

    Cumulative Live Birth Rate achieved after one OPU treatment

    Time frame: Up to 38 weeks after the embryo transfer

Secondary outcomes

  1. Abortion rate

    The spontaneous miscarriage of women in both groups

    Time frame: Up to 2nd trimester miscarriages

  2. DaC rate

    The rate of the dilation and curretage rate in both groups

    Time frame: during pregnancy according to Greek Law

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2022; primary completion for Dec 2023, 14 months later.

Of 209 non-industry observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 100. This study's planned 14 months is below that.

Counting every sponsor, half of 242 studies reached it within 39 months; a quarter within 16 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2022
First posted
Sep 21, 2022
StartEst.
Oct 2022
Primary completionEst.
Dec 2023
CompletionEst.
Mar 2024
Last update
Sep 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05547555
Lead sponsor
Assisting Nature
Responsible party
Papanikolaou Evaggelos (MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic, Assisting Nature) — Principal investigator
First posted
Sep 21, 2022
Start date
Oct 2022 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Mar 2024 (estimated)
Last update
Sep 21, 2022

Study contacts

Evangelos Papanikolaou, MD, PhD
Contact
drvagpapanikolaou@yahoo.gr
00302310424294
Maria Galiotou, MSc
Contact
galiotou@assistingnature.gr
00302310424294

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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