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

NCT06524648 | Recruiting

• 1 other identifier: IGX1-EES-CR-23-01
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

Infertility

Keywords

Infertility; In vitro fertilization; Time lapse; niPGT-A; Embryo Development; Embryonic cell-free DNA; Morphokinetics; Artificial Intelligence; Embryo selection; Blastocyst; Ongoing pregnancy rate

Outcome Measures

Primary Outcomes (1)

• Identification of embryo morphokinetic parameters which correlate with niPGT-A results

  Comparison of embryo morphokinetic parameters from the time-lapse (day 0 to day 6/7) with the niPGT-A results (informativity and ploidy)

  Up to 6/7 days

Secondary Outcomes (12)

• Correlation between the implantation rate (IR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)

  Up to 4 weeks after the embryo transfer

• Correlation between the clinical pregnancy rate (CPR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)

  Up to 5-6 weeks after the embryo transfer

• Correlation between the biochemical pregnancy rate (BPR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)

  Around 2 weeks after the embryo transfer

• Correlation between the ectopic pregnancy rate (EPR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)

  Up to 4-5 weeks after the embryo transfer

• Correlation between the clinical miscarriage rate (CMR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)

  Over 12 gestational weeks

Other Outcomes (1)

• To evaluate the relathionship of the cell-free DNA (cfDNA) concentration of the spent blastocyst media (SBM) with morphokinetic parameters and/or niPGT-A

  Up to 6/7 days of embryo development

Study Arms (1)

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.

Diagnostic Test: niPGT-A

Interventions

niPGT-A DIAGNOSTIC_TEST

Embryos will be cultured, from oocyte fertilization up to day 6/7 of development, in a time lapse system following the standard practice. On day 6/7, embryos will be vitrified and the embryos's media will be collected for niPGT-A analysis. Patients will undergo a single embryo transfer (SET) following the niPGT-A report indications. In the event of 1 or more embryos with the same niPGT-A score, the embryo for transfer will be determined by the site standard practice (morphology or time-lapse score). Patients who do not achieve a pregnancy after a niPGT-A guided SET can undergo as many niPGT-A guided SET or COS+niPGT-A cycles as they need to get pregnant, while the study recruitment phase is active.

Infertile women with medical recommendation of niPGT-A

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Infertile women complying with the selection criteria who are patients at an assisted reproduction center and, by medical recommendation, are undergoing a fertility treatment with non-invasive preimplantational genetic testing for aneuploidies.

You may qualify if:

• 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.

You may not qualify if:

• Embryos with abnormal fertilization (different from 2PN). (Note: In case of no 2PN embryos, patients may repeat the COS cycle).
• Female/couple with PGT-M and/or PGT-SR indication.
• Assisted hatching and/or artificial collapse before media collection.
• Known abnormal karyotype.
• Pathologies or malformations affecting the uterine cavity (polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx) during the patient's participation. (Note: patients are allowed to participate if the pathology is previously operated at least 3 months before patient enrollment).
• Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.

Sponsors & Collaborators

• Igenomix: lead

Study Sites (8)

Kinderwunsch Institut Schenk

Dobl, A-8143, Austria

RECRUITING

Fertty

Barcelona, Barcelona, 08010, Spain

RECRUITING

Hospital Ruber Internacional

Madrid, Madrid, 28034, Spain

RECRUITING

Next Fertility Murcia

Murcia, Murcia, 30007, Spain

RECRUITING

Next Fertility Sevilla

Seville, Sevilla, 41012, Spain

RECRUITING

Next Fertility Valencia

Valencia, Valencia, 46009, Spain

RECRUITING

Vida Recoletas Sevilla

Seville, 41092, Spain

RECRUITING

Orchid IVF Clinic

Dubai, United Arab Emirates

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Spent blastocyst media with embryonic cell-free DNA will be collected for DNA analysis by niPGT-A

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Luis Navarro, PhD

  Igenomix

  PRINCIPAL INVESTIGATOR

• Carmen Rubio, PhD

  Igenomix

  STUDY CHAIR

Central Study Contacts

Carlos Gomez, BSc MSc

CONTACT

+34963905310; carlos.gomez@igenomix.com

Ianae Ceschin, MSc

CONTACT

embrace@igenomix.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: October 29, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); AU (1); AE (1)