ANXA5 M2 Haplotyping in IVF Patients and Embryos

Active, not recruiting

• Conditions: Infertility; Miscarriage, Recurrent; Pregnancy Complications
• Interventions: Other: M2 Test

• Registration Number: NCT04544462
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All couples above the age of 18

Exclusion Criteria

• Any case where biological parental DNA is unavailable.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infertile patients	M2 Test	Patients attending an IVF center for infertility treatment

Primary Outcome Measures

Name	Time	Method
M2 Haplotype frequency	1 month	Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment.

Trial Locations

Locations (1)

Genomic Prediction Clinical Laboratory; 🇺🇸 North Brunswick, New Jersey, United States