A Prospective, Multicenter, Observational Pilot Study to Evaluate the Combination of niPGT-A and Morphokinetics for the Non-invasive Assessment of Embryo Development

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 42
Healthy Volunteers: f
View:

• Study ICF signature.

• Female age between 20 and 42 years (bot included).

• IVF, ICSI or IVF/ICSI performed in fresh own or donated oocytes. Note: donor sperm is allowed.

• niPGT-A cases with a deferred SET (of a day 6/7 vitrified blastocyst) for any medical indication.

• Embryos cultured individually in a TL system from day 0/1 to day 6/7.

Locations
Other Locations
Austria
Kinderwunsch Institut Schenk
RECRUITING
Dobl
Spain
Fertty
RECRUITING
Barcelona
Hospital Ruber Internacional
RECRUITING
Madrid
Next Fertility Murcia
RECRUITING
Murcia
Next Fertility Sevilla
RECRUITING
Seville
Vida Recoletas Sevilla
RECRUITING
Seville
Next Fertility Valencia
RECRUITING
Valencia
United Arab Emirates
Orchid IVF Clinic
RECRUITING
Dubai
Contact Information
Primary
Carlos Gomez, BSc MSc
carlos.gomez@igenomix.com
+34963905310
Backup
Ianae Ceschin, MSc
embrace@igenomix.com
Time Frame
Start Date: 2024-10-29
Estimated Completion Date: 2027-01
Participants
Target number of participants: 200
Treatments
Infertile women with medical recommendation of niPGT-A
Patients will not undergo any additional intervention apart from those already scheduled for their ART. The only study specific procedures are the culture of the embryos in a timelapse system and the collection of the embryo's culture media, which is usually discarded. Both procedures will be performed following the stardard practice.~No drugs will be administered as per the study.
Related Therapeutic Areas
Sponsors
Leads: Igenomix

This content was sourced from clinicaltrials.gov