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Embryo Health Study (EHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528498
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Genomic Prediction Inc.

Study Description
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Brief Summary:
This study intends to determine the patients' perception and motivation to obtain additional information on their preimplantation embryos' risks of polygenic disorders. Patients undergoing IVF and genetic testing on their embryos for aneuploidies will be given the option to obtain information of their embryos' polygenic disease risk after receiving genetic counseling.

Condition or disease Intervention/treatment
Infertility Hereditary Diseases Other: Preimplantation Genetic Testing

Detailed Description:

Patients planning to use PGT-A and who meet the inclusion criteria will be offered participation by their IVF physician prior to initiating cycle stimulation. Eligible and interested patients will be contacted, counseled and consented for participation in the study by a Genetic Counselor at Genomic Prediction Clinical Laboratory. This will include genetic counseling to address the benefits and limitations of PGT-A and PGT-P, the family history of diseases currently tested under PGT-P, what diseases they may be interested in testing, the process of obtaining saliva samples, and the information provided by PGT-P results.

A total of 500 patients will complete the study and may be recruited from any IVF clinic in the United States. After being enrolled in the study, patients will have two options. One option is to receive PGT-A results first and then decide if they wish to receive the PGT-P results. A second option is to receive a single comprehensive report. All patients will receive a report indicating the predicted karyotype of each embryo (PGT-A) and, according to which option they elected, may also receive a report on any or all of the following elected diseases: Type 1 Diabetes, Type 2 Diabetes, Coronary Artery Disease, Heart Attack, Hypercholesterolemia, Hypertension, Testicular Cancer, Prostate Cancer, Malignant Melanoma, Breast Cancer, Basal Cell Carcinoma. Furthermore, a genetic ancestry test will be performed on each submitted saliva sample to determine potential PGT-P performance and which disease predictors can be computed based on the patients ethnic background.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Embryo Health Study: Prospective Longitudinal Analysis of PGT-P
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Groups and Cohorts
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Intervention Details:
  • Other: Preimplantation Genetic Testing
    Embryo biopsies will undergo preimplantation genetic testing for aneuploidies as per standard of care, and polygenic disease risk (PGT-P) will be computed for these samples.

Outcome Measures
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Primary Outcome Measures :
  1. Patients' interest in Preimplantation Genetic Testing for Polygenic Disorders [ Time Frame: 2 years ]
    Patients' interest in obtaining information on their embryos' polygenic disease risk will be measured in a scale of 1-5. 1 being "Not interested" and 5 "highly interested".


Biospecimen Retention:   Samples With DNA
Amplified DNA from trophectoderm biopsies of human embryos and from saliva samples.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing IVF with preimplantation genetic testing for aneuploidies (PGT-A).
Criteria

Inclusion Criteria:

  • All couples of Caucasian or East Asian ancestry above the age of 18 who elect to have PGT-A as part of their IVF treatment cycle.

Exclusion Criteria:

  • Any case where biological parental DNA is unavailable.
  • Any case involving PGT-M or PGT-SR.
Contacts and Locations
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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): NCT04528498


Contacts
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Contact: Nathan Treff, PhD (973) 529-4223 clinicaltrials@genomicprediction.com
Contact: Diego Marin, PhD (973) 529-4223 clinicaltrials@genomicprediction.com

Locations
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United States, New Jersey
Genomic Prediction Clinical Laboratory Recruiting
North Brunswick, New Jersey, United States, 08902
Contact: Nathan R Treff, PhD    973-529-4284    nathan@genomicprediction.com   
Contact: Diego Marin, PhD    2012333199 ext Treff    diego@genomicprediction.com   
Principal Investigator: Nathan Treff, PhD         
Sponsors and Collaborators
Genomic Prediction Inc.
More Information
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Responsible Party: Genomic Prediction Inc.
ClinicalTrials.gov Identifier: NCT04528498    
Other Study ID Numbers: Genomic Prediction Inc 616
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be available after publication of the study main findings, either as supplemental material or in a public data repository.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Genetic Diseases, Inborn