Actively Recruiting
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
Eligibility Criteria
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
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
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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