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OpenTrials
Active, Not Recruiting

NCT Number: NCT04544462

ANXA5 M2 Haplotyping in IVF Patients and Embryos

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infertility Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Genital Diseases Miscarriage, Recurrent Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Genomic Prediction Clinical Laboratory

North Brunswick, New Jersey, 08902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All couples above the age of 18

Exclusion criteria

  • Any case where biological parental DNA is unavailable.

Treatment and study plan

M2 Test

Other

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.

Primary outcomes

  1. M2 Haplotype frequency

    Time frame: 1 month

    Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment.

Sponsors and collaborators

Lead sponsor

Genomic Prediction Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2020
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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