North Brunswick Township

This research aims to understand how patients undergoing in vitro fertilization (IVF) perceive and are motivated to receive additional genetic information about their embryos, specifically concerning risks for polygenic disorders. It focuses on patients who are already having their embryos tested for chromosomal abnormalities (aneuploidies) and explores their interest in learning about other inherited disease risks through genetic counseling. The study involves patients planning IVF with preimplantation genetic testing for aneuploidies (PGT-A) and evaluates their choices and responses to receiving polygenic risk information (PGT-P). Patients who meet the criteria will be offered participation by their IVF doctor before starting ovarian stimulation. After consenting and genetic counseling, they can choose to receive PGT-A results first and then decide about PGT-P results, or get a combined comprehensive report covering both. The PGT-P report may include risk predictions for diseases such as Type 1 and Type 2 Diabetes, heart conditions, several cancers, and other hereditary diseases. Each patient will also provide saliva samples for genetic ancestry testing to better understand the accuracy and applicability of polygenic risk predictions based on ethnic background. Participants will be followed for up to two years, during which their interest in polygenic testing will be measured. Genetic counseling will address the benefits and limits of each test, and the study will gather data on patient choices and motivations. Information from embryo biopsies and saliva samples will be collected and analyzed. The study is observational and does not affect the standard IVF treatment. Overall, the study seeks to inform future use of genetic testing in embryo selection and patient decision-making.

Researchers are conducting a long-term study to understand the clinical outcomes and personal experiences of patients who have used preimplantation genetic testing (PGT), a tool often used alongside in vitro fertilization (IVF). This study aims to gather valuable insights that may help improve medical care and support for individuals undergoing PGT. The study involves patients who agree to participate in research when consenting to PGT. Participants will be identified through their consent forms and invited to take part in recorded interviews conducted by a licensed genetic counselor. The study plans to recruit up to 10,000 patients willing to share their experiences. Alongside interviews, patient records and data such as family history and ethnicity may be analyzed, with results shared in scientific publications while protecting patient privacy. During the study, participants will engage in a recorded interview with a genetic counselor to discuss their perspectives on PGT. Researchers will review medical records and analyze collected data over time, focusing on patient views two years after PGT. The study follows all privacy guidelines and aims to contribute knowledge to the medical community. Participation involves ongoing follow-up but does not include treatments or interventions beyond the interview and data collection.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.