ANXA5 M2 Haplotyping in IVF Patients and Embryos

ANXA5 M2 Haplotyping in IVF Patients and Embryos

Sponsors

Lead Sponsor: Genomic Prediction Inc.

Source Genomic Prediction Inc.
Brief Summary

This study aims to characterize the association between history of pregnancy complications and M2 carrier status in IVF patients and the utility of M2 haplotype preimplantation genetic testing (PGT) in embryos produced by carrier couples. Participants in this study will be screened for the M2 variant. History of pregnancy complications and miscarriages will be studied in order to determine potential associations with M2 carrier-ship.

Detailed Description

Patients consenting to participation in the study will receive a saliva collection kit for M2 testing. Genomic Prediction Clinical Laboratory will perform testing and issue a report per routine clinical procedures. Upon completion of issuing a report, the patients' medical records will be obtained from the IVF Center providing care to the patient. Information obtained may include: history of miscarriage, embryo transfer outcomes, preeclampsia, small for gestation age baby, or thrombophilia disorders. 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.

Overall Status Recruiting
Start Date 2020-02-10
Completion Date 2022-03-01
Primary Completion Date 2021-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
M2 Haplotype frequency 1 month
Enrollment 500
Condition
Intervention

Intervention Type: Other

Intervention Name: M2 Test

Description: 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.

Arm Group Label: Infertile patients

Eligibility

Sampling Method:

Probability Sample

Criteria:

Inclusion Criteria: - All couples above the age of 18 Exclusion Criteria: - Any case where biological parental DNA is unavailable.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Nathan Treff, PhD

Phone: (973) 529-4223

Email: [email protected]

Location
Facility: Status: Contact: Genomic Prediction Clinical Laboratory Leslie Duffy, BA 973-529-4223 [email protected]
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Infertile patients

Description: Patients attending an IVF center for infertility treatment

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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