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ANXA5 M2 Haplotyping in IVF Patients and Embryos

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04544462
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : April 21, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Infertility Miscarriage, Recurrent Pregnancy Complications Other: M2 Test

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ANXA5 M2 Haplotyping in IVF Patients and Embryos
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort Intervention/treatment
Infertile patients
Patients attending an IVF center for infertility treatment
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.

Primary Outcome Measures :
  1. M2 Haplotype frequency [ Time Frame: 1 month ]
    Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment.

Biospecimen Retention:   Samples With DNA
Saliva swabs will be collected from participants. DNA will be extracted and used to screen for the M2 haplotype.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All couples above the age of 18 seeking infertility treatment at IVF centers

Inclusion Criteria:

  • All couples above the age of 18

Exclusion Criteria:

  • Any case where biological parental DNA is unavailable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04544462

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Contact: Nathan Treff, PhD (973) 529-4223
Contact: Diego Marin, PhD (973) 529-4223

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United States, New Jersey
Genomic Prediction Clinical Laboratory Recruiting
North Brunswick, New Jersey, United States, 08902
Contact: Leslie Duffy, BA    973-529-4223   
Sponsors and Collaborators
Genomic Prediction Inc.
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Responsible Party: Genomic Prediction Inc. Identifier: NCT04544462    
Other Study ID Numbers: Genomic Prediction Inc 625
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications
Abortion, Habitual