ClinicalTrials.Veeva

Menu

ANXA5 M2 Haplotyping in IVF Patients and Embryos

G

Genomic Prediction

Status

Active, not recruiting

Conditions

Pregnancy Complications
Infertility
Miscarriage, Recurrent

Treatments

Other: M2 Test

Study type

Observational

Funder types

Industry

Identifiers

NCT04544462
Genomic Prediction Inc 625

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All couples above the age of 18

Exclusion criteria

  • Any case where biological parental DNA is unavailable.

Trial design

500 participants in 1 patient group

Infertile patients
Description:
Patients attending an IVF center for infertility treatment
Treatment:
Other: M2 Test

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems