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Multi-center Study to Validate niPGT-A (niPGT-A)

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ClinicalTrials.gov Identifier: NCT03520933
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Igenomix

Brief Summary:

Abnormal chromosome number, or aneuploidy, is common in human embryos. It is responsible for more than half of all miscarriages, and it is the leading cause of congenital birth defects. Besides, it has been described that aneuploidy may also affect embryo implantation. Therefore, selecting embryos that have the best chance of implanting and growing into a healthy baby is one of the most important steps in the field of assisted reproduction.

Recent advances in genetic technologies, such as Next-Generation Sequencing (NGS), have allowed aneuploidy to be detected with greater sensitivity. The application of this technique to trophectoderm biopsies, taken from embryos before transfer to the uterus, has provided insight into the clinical impact of chromosomal status. This process of screening embryos to make sure they have the right number of chromosomes and to look for any structural abnormalities in the chromosomes is called Preimplantation Genetic Testing for Aneuploidy (PGT-A). It requires specific equipment and trained personnel that will add costs and risks, so non-invasive techniques are sought as an alternative. These non-invasive procedures has been explored by some groups analyzing the spent culture medium where the embryo is incubated up to the time of transfer or freezing. In daily routine, this media is discarded after finishing the embryo culture, but it has been reported that contains traces of embryonic cell-free DNA (cfDNA) that can represent the genetic load of the embryo. However, at the moment there is a high variability in results across studies, with a percentage of concordant results between the media and the trophectoderm biopsy ranging from 3.5 to 85.7%.

Thus, the main objective of this project is to validate a new non-invasive method for PGT-A (niPGT-A), based on improved collection and analysis of the culture media to achieve higher rates of sensitivity and specificity and to decrease the effect of some intrinsic difficulties such as low embryonic cfDNA input, mosaicism and maternal contamination.


Condition or disease Intervention/treatment
Aneuploidy Chromosome Abnormality Infertility Diagnostic Test: PGT-A Diagnostic Test: niPGT-A

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Study Type : Observational
Estimated Enrollment : 2620 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Observational, Multi-center, International Study to Validate a Non-invasive Preimplantation Genetic Test for Embryo Aneuploidy in the Spent Culture Media (niPGT-A).
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Group/Cohort Intervention/treatment
Embryos undergoing PGT-A / niPGT-A
Embryos from IVF patients between 20 and 44 years of age, undergoing PGT-A for any medical indication, with own oocytes or ovum donation cycles and with single embryo transfer (SET)
Diagnostic Test: PGT-A
PGT-A will be carried out following the usual clinical practice: Trophectoderm biopsy samples from blastocysts are analyzed by NGS to screen for numerical chromosomal abnormalities.

Diagnostic Test: niPGT-A
Non-invasive preimplantation genetic test for embryo aneuploidy analyzing the spent culture media where the embryo is incubated up to the time of transfer or freezing. This media contains traces of embryonic cell-free DNA (cfDNA) that can represent the genetic load of the embryo.




Primary Outcome Measures :
  1. Chromosomal status of the embryos [ Time Frame: 6 to 7 days of embryo development ]
    Number and structure of the chromosomes


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 20 weeks ]
    Number of pregnancies per embryo transfer

  2. Clinical miscarriage [ Time Frame: 20 weeks ]
    Number of clinical miscarriages per total number of pregnancies

  3. POC (Products of Conception ) [ Time Frame: Up to 20 weeks ]
    Placental and/or fetal tissue that remains in the uterus after a spontaneous pregnancy loss

  4. Live birth rate [ Time Frame: 40 weeks ]
    Number of babies born per embryo transfer


Biospecimen Retention:   Samples With DNA
  • Culture media: Embryonic cell-free DNA (cfDNA)
  • Trophectoderm biopsy
  • Full blastocysts


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   IVF patients
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Embryos from IVF patients between 20 and 44 years of age, undergoing PGT-A for any medical indication, with own oocytes or ovum donation cycles and with single embryo transfer (SET).
Criteria

Inclusion Criteria:

  • PGT-A cases with trophectoderm biopsy and SET for any medical indication and signed written informed consent form approved by the EC/IRB after having been duly informed of the nature of the research and voluntarily accepted to participate in the study.
  • ICSI (Intra Cytoplasmic Sperm Injection), IVF (In Vitro Fertilization) or ICSI/IVF performed in fresh oocytes from couples are allowed.

Note: Donor sperm is allowed.

  • Only fresh oocytes allowed.
  • Fresh and Deferred Embryo Transfer are allowed. Note: In case of Deferred Embryo Transfer, embryos must be vitrified always after the blastocyst biopsy.
  • Age: 20-44 years of age (both included).

Exclusion Criteria:

  • A known abnormal karyotype in a member of the couple.
  • Preimplantation Genetic Testing for Monogenic diseases (PGT-M) or Preimplantation Genetic Testing for Structural Rearrangements (PGT-SR) cases excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520933


Contacts
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Contact: Carlos Gomez, BSc MSc +34963905310 carlos.gomez@igenomix.com
Contact: Diana Valbuena, MD PhD +34963905310 diana.valbuena@igenomix.com

Locations
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United States, California
San Diego Fertility Center Recruiting
San Diego, California, United States, 92130
Contact: William Venier, MSC    858-794-6363    bvenier@sdfertility.com   
United States, Massachusetts
Boston IVF Fertility Clinic Recruiting
Boston, Massachusetts, United States, 02109
Contact: Denny Sakkas, MD PhD    888-300-2438    DSakkas@BOSTONIVF.com   
United States, Washington
Dominion Fertility Recruiting
Arlington, Washington, United States, 22203
Contact: Natilie Sofia, BSc RN    703-920-3890    natalie@dominionfertility.com   
Contact: Michael Dimattina, MD PhD    +1 703-920-3890    mikedima@mac.com   
Argentina
Pregna Medicina Reproductiva Recruiting
Buenos Aires, Argentina, C1425DGQ
Contact: Laura Kopcow, MD PhD    (+54) 4831-5900    lkopcow@pregna.com.ar   
Brazil
Nilo Frantz - Centro de Reprodução Humana Recruiting
Boa Vista, Porto Alegre, Brazil, 91330-002
Contact: Nilo Frantz, MD    + 55 51 3328 4680    nilo@nilofrantz.com.br   
Contact: Marcos Iuri Roos Kulmann, BS    +55 51 3328.4680    marcosiuri@nilofrantz.com.br   
Italy
Genera Rome Recruiting
Rome, Roma, Italy, 00197
Contact: Laura Rienzi, MD PhD    (+39) 063269791    rienzi@generaroma.it   
Mexico
NASCERE Recruiting
Mexico City, Cdmx, Mexico, 05120
Contact: Lucia Daniela Garcia Montes, BS PhD    (+52) 15554521311    lucia.daniela.garcia.montes@gmail.com   
Contact: Gerardo Barroso, MD PhD    (+52) 15554521311    barrosog@me.com   
Principal Investigator: Gerardo Barroso, MD PhD         
Peru
Inmater - Clínica de Fertilidad Recruiting
Lima, Peru, 15036
Contact: Luis Ernesto Escudero Velando, MD, MSc    51 01 4762727    ernestoescudero@hotmail.com   
Principal Investigator: Luis Ernesto Escudero Velando, MD, MSc         
Spain
ProcreaTec Recruiting
Madrid, Spain, 28036
Contact: Alexandra Izquierdo, MD PhD    (+34) 914585804    alexandraizquierdo@procreatec.com   
Turkey
Bahçeci Group Recruiting
Istanbul, Turkey, 07720
Contact: Necati Findikli, BS MSc PhD    (+90) 2123103100    nfindikli@bahceci.com   
Contact: Mustafa Bahceci, MD PhD    (+90) 2123103166    mbahceci@bahceci.com   
Sponsors and Collaborators
Igenomix
Investigators
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Principal Investigator: Carmen Rubio, BSc PhD Igenomix
Study Chair: Carlos Simón, MD PhD Igenomix
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Responsible Party: Igenomix
ClinicalTrials.gov Identifier: NCT03520933    
Other Study ID Numbers: IGX1-NIP-CS-18-02-SUB1
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Igenomix:
Embryo
Blastocyst
Non-invasive
PGT-A
Chromosome
Aneuploidy
Spent culture medium
Trophectoderm biopsy
Additional relevant MeSH terms:
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Infertility
Chromosome Disorders
Aneuploidy
Chromosome Aberrations
Congenital Abnormalities
Pathologic Processes
Genetic Diseases, Inborn