Genetic testing for embryos in older women undergoing IVF
GEnetic Testing in Elective Single Embryo Transfer in Women of Advanced Maternal Age
This study is testing if using genetic testing on embryos can help women aged 35 to 40 have a better chance of getting pregnant through IVF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 35 Years to 40 Years |
| Sex | Female |
| Sponsor | Genomic Prediction Inc. Industry-sponsored |
| Locations | 1 site (Margate, Florida) |
| Trial ID | NCT04167748 on ClinicalTrials.gov |
What this trial studies
The GETSET trial is a randomized controlled trial aimed at evaluating the outcomes of preimplantation genetic testing for aneuploidies (PGT-A) in women aged 35 to 40 undergoing elective single embryo transfer. A total of 240 participants will be recruited and divided into two groups: one receiving standard embryo transfer with untested embryos and the other receiving transfer of genetically tested euploid embryos. The study will assess the impact of PGT-A on conception rates and overall success in this demographic. Participants will undergo standard IVF procedures, including ovarian stimulation and embryo culture, followed by either a frozen embryo transfer or additional cycles based on the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 35 to 40 who are undergoing IVF and have at least one evaluable blastocyst.
Not a fit: Patients with anovulatory PCOS, those utilizing donor oocytes, or those with a history of recurrent pregnancy loss or implantation failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pregnancy rates and reduce the risk of miscarriage in older women undergoing IVF.
How similar studies have performed: Previous studies have shown promising results with preimplantation genetic testing, indicating potential benefits in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women undergoing IVF of between 35 and 40 years of age at IVF cycle start * Utilization of Intracytoplasmic Sperm Injection ICSI * Utilization of ejaculated or testicular sperm * Utilization of autologous or donor sperm * All Controlled Ovarian Hyperstimulation (COH) protocols Exclusion criteria: * Patients with anovulatory Polycystic ovarian syndrome (PCOS) * Utilization of donor oocytes * Utilization of gestational carrier * Recurrent Pregnancy Loss (RPL) defined as ≥ 3 consecutive miscarriages * Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers
Where this trial is running
Margate, Florida
- IVF Florida Reproductive Associates — Margate, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Nathan R Treff, PhD — Genomic Prediction
- Study coordinator: Nathan R Treff, PhD
- Email: nathan@genomicprediction.com
- Phone: (973) 529-4223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.