Whole genome sequencing of IVF embryos to study mutation rates related to paternal age
Study of the Effect of Paternal Age on de Novo Mutation Rate by Using Whole Genome Sequencing of IVF Embryos
This study is testing how a father's age affects genetic changes in IVF embryos to help couples understand the risks when using older sperm.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | All |
| Sponsor | GenEmbryomics Pty. Ltd Industry-sponsored |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Trial ID | NCT05739890 on ClinicalTrials.gov |
What this trial studies
This project investigates the impact of paternal age on de novo mutation rates in IVF embryos using whole genome sequencing. It involves re-biopsying embryos that are unsuitable for transfer due to genetic abnormalities and comparing the results of whole genome sequencing with traditional targeted sequencing methods. The study aims to derive mutation rates and understand the risks associated with advanced paternal age, utilizing a paired non-inferiority design. Couples undergoing IVF with at least one unsuitable embryo will participate, providing valuable insights into fertility and genetic risks.
Who should consider this trial
Good fit: Ideal candidates are couples undergoing IVF with at least one embryo deemed unsuitable for transfer due to genetic or chromosomal abnormalities.
Not a fit: Patients with low ovarian reserve or those without suitable embryo samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of genetic risks in IVF embryos, potentially improving fertility outcomes.
How similar studies have performed: While the approach of using whole genome sequencing in this context is innovative, similar studies have shown promise in understanding genetic factors in IVF.
Eligibility criteria
Show full inclusion / exclusion criteria
Couples undergoing IVF with 1≥ embryo sample unsuitable for transfer due to genetic or chromosome abnormalities. Cases with parental DNA available directly or consenting follow-up. Exclusion Criteria: * Female patients with low ovarian reserve (\< 10 follicles or FSH\>10, AMH \<1).
Where this trial is running
New York, New York and 3 other locations
- Neway Fertility — New York, New York, United States (Not_yet_recruiting)
- ORM Fertility — Portland, Oregon, United States (Not_yet_recruiting)
- Poma Fertility — Kirkland, Washington, United States (Not_yet_recruiting)
- Preimplantation Genetic Testing Unit ART and Reproductive Genetics Unit, Memorial Sisli Hospital — Istanbul, Okmeydani-Sisli, Turkey (Recruiting)
Study contacts
- Principal investigator: Nicholas Murphy, PhD — GenEmbryomics Pty. Ltd
- Study coordinator: Santiago Munné, PhD
- Email: santiago.munne@gmail.com
- Phone: +1-646-2072897
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.