Investigating outcomes of transferring mosaic embryos in infertility treatment
A Prospective Study of a Mosaic Embryo Transfer
This study is trying to see if transferring mosaic embryos, which have both normal and abnormal cells, can help women aged 18-45 who are undergoing IVF have successful pregnancies and live births.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Colorado Center for Reproductive Medicine Academic / other |
| Locations | 1 site (Lone Tree, Colorado) |
| Trial ID | NCT04472156 on ClinicalTrials.gov |
What this trial studies
This research investigates the clinical outcomes of transferring mosaic embryos, which contain both normal and abnormal cells, that have been screened using preimplantation genetic testing (PGT). The study involves women aged 18-45 who have undergone an IVF cycle at the Colorado Center for Reproductive Medicine and have a mosaic embryo available for transfer. The aim is to evaluate implantation and live birth rates to determine if these embryos should be routinely offered for transfer, despite current practices that typically exclude them. The study seeks to enhance understanding of the relationship between embryonic mosaicism and successful pregnancies.
Who should consider this trial
Good fit: Ideal candidates are infertile women aged 18-45 who have completed an IVF cycle with PGT and have a mosaic embryo available for transfer.
Not a fit: Patients who do not meet the clinical requirements for embryo transfer or those desiring more than a single embryo transfer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new options for infertile patients by demonstrating that mosaic embryos can lead to healthy pregnancies.
How similar studies have performed: Previous studies have shown that mosaic embryos can result in healthy live births, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women age 18-45 Infertile women who have completed an IVF cycle with PGT at the Colorado Center for Reproductive Medicine (CCRM) that have a mosaic embryo * Patients can be of any race, culture, sexual orientation or ethnicity * Patients that are willing to transfer a single embryo Exclusion Criteria: * Patients that do not meet the clinical requirements for an embryo transfer per clinic standards. * Patients that desire more than a single embryo transfer. * Patients that are using a gestational carrier. * Embryonic mosaic PGT results that include chromosome errors 13, 18, 21 * Patients that did not complete their IVF with PGT cycle at the Colorado Center for Reproductive Medicine.
Where this trial is running
Lone Tree, Colorado
- Colorado Center for Reproductive Medicine — Lone Tree, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Mandy Katz-Jaffe, PhD — Fertility Genetics
- Study coordinator: Rachel Makloski, RN
- Email: rmakloski@colocrm.com
- Phone: 303-788-8300
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.