Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2020-02-10
2026-12-31
Brief Summary
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Detailed Description
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In addition to obtaining records related to history of pregnancy complications, carrier couples will be offered the use of preimplantation genetic testing for M2 carrier status (PGT-M2) in their embryos. Patients electing to perform PGT-M2 will receive PGT-A according to standard clinical practice, along with M2 carrier status.
A total of 500 patients will complete the study and may be recruited from any IVF clinic in the United States. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by each clinic.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Infertile patients
Patients attending an IVF center for infertility treatment
M2 Test
DNA will be extracted from saliva samples obtained from participants. Genetic testing will be performed to screen for the M2 mutation and determine the carrier status of each patient and partner.
Interventions
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M2 Test
DNA will be extracted from saliva samples obtained from participants. Genetic testing will be performed to screen for the M2 mutation and determine the carrier status of each patient and partner.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Genomic Prediction Inc.
INDUSTRY
Responsible Party
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Locations
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Genomic Prediction Clinical Laboratory
North Brunswick, New Jersey, United States
Countries
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Other Identifiers
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Genomic Prediction Inc 625
Identifier Type: -
Identifier Source: org_study_id
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