A Prospective Study of a Mosaic Embryo Transfer

Colorado Center for Reproductive Medicine

Status: Enrolling

Conditions: Infertility

Treatments: Procedure: Transfer of mosaic embryo

Study type: Interventional

Funder types: Other

Identifiers

NCT04472156

Mosaic

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Transfer of mosaic embryo

Experimental group

Description:

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.

Treatment:

Procedure: Transfer of mosaic embryo