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NCT04544462 Clinical Trial

ANXA5 M2 Haplotyping in IVF Patients and Embryos

Infertility Clinical Trial

Official title:
ANXA5 M2 Haplotyping in IVF Patients and Embryos

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04544462
Other study ID # Genomic Prediction Inc 625
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 10, 2020
Est. completion date December 2023

Study information
Verified date May 2023
Source Genomic Prediction Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All couples above the age of 18 Exclusion Criteria: - Any case where biological parental DNA is unavailable.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
United States Genomic Prediction Clinical Laboratory North Brunswick New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Genomic Prediction Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary M2 Haplotype frequency Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment. 1 month
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