InfertilityNCT04544462
ANXA5 M2 Haplotyping in IVF Patients and Embryos
An observational study of Infertility and Miscarriage, Recurrent, run by Genomic Prediction Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infertility, Miscarriage, Recurrent, Pregnancy Complications
- What is being tested?
- M2 Test
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All couples above the age of 18 seeking infertility treatment at IVF centers
Who may be able to join
- All couples above the age of 18
Who cannot join
- Any case where biological parental DNA is unavailable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Genomic Prediction Clinical Laboratory
North Brunswick, New Jersey, 08902
About this study
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.
Read the 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.
- Conditions
- Infertility, Miscarriage, Recurrent, Pregnancy Complications
- Being tested
- M2 Test
- Medical subject headings
- Infertility, Abortion, Habitual, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M2 TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Infertile patients | Patients attending an IVF center for infertility treatment Receives: Other: M2 Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
M2 Haplotype frequency
Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start10 Feb 2020
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genomic Prediction Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544462
- Sponsor's protocol ID
- Genomic Prediction Inc 625
- Status last verified
- Aug 2025
- First submitted
- 3 Sep 2020
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANXA5 M2 Haplotyping in IVF Patients and Embryos
- ClinicalTrials.gov ID
- NCT04544462
- Acronym / sponsor ID
- Genomic Prediction Inc 625
- Conditions
- Infertility, Miscarriage, Recurrent, Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Genomic Prediction Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile patients | – | Other: M2 TestPatients attending an IVF center for infertility treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All couples above the age of 18 seeking infertility treatment at IVF centers
Key inclusion criteria (1 listed)
- All couples above the age of 18
Key exclusion criteria (1 listed)
- Any case where biological parental DNA is unavailable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M2 TestDNA 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. | Other | Infertile patients |
Primary outcome
M2 Haplotype frequency
Time frame: 1 month
Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Miscarriage, Recurrent, run by Genomic Prediction Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M2 Haplotype frequency (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.