A Prospective Study of a Mosaic Embryo Transfer

C

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)

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

Trial contacts and locations

1

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Central trial contact

Rachel Makloski, RN

Data sourced from clinicaltrials.gov

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