ANXA5 M2 Haplotyping in IVF Patients and Embryos
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- M2 Haplotype frequency [1 month]
Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All couples above the age of 18
Exclusion Criteria:
- Any case where biological parental DNA is unavailable.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genomic Prediction Clinical Laboratory | North Brunswick | New Jersey | United States | 08902 |
Sponsors and Collaborators
- Genomic Prediction Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Genomic Prediction Inc 625