A Prospective Study of a Mosaic Embryo Transfer

Not Applicable

Recruiting

• Conditions: Infertility
• Interventions: Procedure: Transfer of mosaic embryo

• Registration Number: NCT04472156
• Lead Sponsor: Colorado Center for Reproductive Medicine

Brief Summary

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).

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.

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-15
• Study Start: 2020-10-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2026-06-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transfer of mosaic embryo	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.

Primary Outcome Measures

Name	Time	Method
Live birth rate	9-12 months post embryo transfer	Live birth rate will be evaluated
Evaluation of Implantation rate	3-4 weeks after embryo transfer	Ultrasound will be performed 2-3 weeks after initial positive pregnancy test to confirm viable pregnancy as evidenced by gestational sac in the uterus with a fetal heat rate

Secondary Outcome Measures

Name	Time	Method
Pregnancy complications	9-12 months post embryo transfer	Patient will be evaluated after delivery to assess if patient had any complications associated with the pregnancy. This will be completed with telephone interview
Stillbirth rates associated with Mosaic Embryo Transfer	9-12 months post embryo transfer	The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer
Miscarriage Rates	5-12 months post embryo transfer	The rate of miscarriage will be evaluated associated with a mosaic embryo transfer
Prenatal testing	9-12 months post embryo transfer	If available, we will request any results of prenatal testing of karyotype that was obtained via Amniocentesis or Chorionic Villa Sampling (CVS)
Products of conception from miscarriage	2-9 months post embryo transfer	Products of conception will be karyotyped if available following a miscarriage and compared to that of previous PGT testing if the patient is willing to have the testing.
Neonatal Outcomes	12-15 months after birth of baby	Patient will be contacted to assess the health of the infant, noting any medical problems if any that the baby has.

Trial Locations

Locations (1)

Colorado Center for Reproductive Medicine; 🇺🇸 Lone Tree, Colorado, United States