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
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Infertility
• Miscarriage, Recurrent
• Pregnancy Complications

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