Actively Recruiting

Age: 20Years - 42Years
FEMALE
NCT06524648

International Pilot Study for Dual Non-invasive Assesment of Embryo Development

Led by Igenomix · Updated on 2025-08-01

200

Participants Needed

8

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Choosing the best embryo is one of the major challenges for achieving success in in vitro fertilization (IVF). Traditionally, embryo evaluation has been based on morphological quality (how the embryo looks like) and chromosomal status as diagnosed by a genetic testing. However, recently new techniques that do not require manipulation of the embryo have been developed and have shown promising results. The goal of this observational study is, by combining two non-invasive techniques, to find out some parameters during embryo development which may be related with the embryo's chromosomic status. For that, infertile women planning to undergo an IVF/ICSI treatment with a recommended niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) will be invited to join the study. The main question it aims to answer is: * Can morphokinetics parameters correlate with embryo chromosomal status? Participants will follow their previously programmed IVF/ICSI treatment and no additional visits/interventions will be required by their participation in the study. The obtained embryos will be cultured in a time-lapse system instead of in a conventional incubator, and niPGT-A will be performed. Following the standard practice, a deferred single embryo transfer (SET) will be performed according to the niPGT-A results. After the transfer, patients will be followed-up as usual.

CONDITIONS

Official Title

International Pilot Study for Dual Non-invasive Assesment of Embryo Development

Who Can Participate

Age: 20Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form for the study
  • Female aged between 20 and 42 years inclusive
  • Undergoing IVF, ICSI, or combined IVF/ICSI with fresh own or donated oocytes (donor sperm allowed)
  • Cases planned for niPGT-A with deferred single embryo transfer of day 6/7 vitrified blastocysts
  • Embryos cultured individually in a time-lapse system from day 0/1 to day 6/7
Not Eligible

You will not qualify if you...

  • Embryos with abnormal fertilization other than 2 pronuclei (2PN); patients may repeat cycle if no 2PN embryos
  • Female or couple with indication for PGT-M or PGT-SR
  • Assisted hatching or artificial collapse performed before media collection
  • Known abnormal karyotype
  • Uterine pathologies or malformations affecting cavity (e.g., polyps, large myomas 6cm, submucosal myomas, septum, hydrosalpinx) unless previously operated at least 3 months before enrollment
  • Any unstable illness or medical condition that risks patient safety or compliance according to medical criteria

AI-Screening

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Trial Site Locations

Total: 8 locations

1

Kinderwunsch Institut Schenk

Dobl, Austria, A-8143

Actively Recruiting

2

Fertty

Barcelona, Barcelona, Spain, 08010

Actively Recruiting

3

Hospital Ruber Internacional

Madrid, Madrid, Spain, 28034

Actively Recruiting

4

Next Fertility Murcia

Murcia, Murcia, Spain, 30007

Actively Recruiting

5

Next Fertility Sevilla

Seville, Sevilla, Spain, 41012

Actively Recruiting

6

Next Fertility Valencia

Valencia, Valencia, Spain, 46009

Actively Recruiting

7

Vida Recoletas Sevilla

Seville, Spain, 41092

Actively Recruiting

8

Orchid IVF Clinic

Dubai, United Arab Emirates

Actively Recruiting

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Research Team

C

Carlos Gomez, BSc MSc

CONTACT

I

Ianae Ceschin, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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