A Prospective Study of a Mosaic Embryo Transfer
Purpose
This research is a prospective study in which the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT).
Condition
- Infertility
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Outcomes will be evaluated with women who have a mosaic embryo transferred
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Transfer of mosaic embryo |
Women will have a mosaic embryo transferred to their uterus after in vitro fertilization (IVF) with pre implantation genetic testing completed at Colorado Center for Reproductive Medicine. |
|
Recruiting Locations
Lone Tree, Colorado 80124
More Details
- NCT ID
- NCT04472156
- Status
- Recruiting
- Sponsor
- Colorado Center for Reproductive Medicine
Detailed Description
This research is a prospective study with the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT). PGT involves the biopsy and testing of a handful (3-6) of trophectoderm (pre-placental cells) from the embryo. Embryos that are screened as mosaic via PGT, as a standard, are not offered for transfer for pregnancy attempt. Publications have shown that mosaic embryos and mosaic fetuses can result in healthy live births (Wallerstein et al, 2015; Victor et al, 2019). Ongoing clinical outcomes are important to further understand the association between an embryonic mosaic biopsy of pre-placental cells and subsequent fetal chromosomal constitution. Implantation rates and live birth rates will be evaluated to help understand if mosaic embryos should routinely be offered for transfer to patients attempting pregnancy.