A Prospective Study of a Mosaic Embryo Transfer

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).

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Procedure: Transfer of mosaic embryo

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Makloski, RN; Phone Number: 1769 303-788-8300; Email: rmakloski@colocrm.com

Study Locations

• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • Colorado Center for Reproductive Medicine
      • Contact: Rachel Makloski, RN; Email: TriggerStudy@colocrm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Transfer of mosaic embryo; Subjects will transfer a mosaic embryo transferred to their uterus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Implantation rate	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	3-4 weeks after embryo transfer
Live birth rate	Live birth rate will be evaluated	9-12 months post embryo transfer

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Colorado Center for Reproductive Medicine
• Investigators: Principal Investigator: Mandy Katz-Jaffe, PhD, Fertility Genetics

Publications and helpful links

General Publications

• Wallerstein R, Misra S, Dugar RB, Alem M, Mazzoni R, Garabedian MJ. Current knowledge of prenatal diagnosis of mosaic autosomal trisomy in amniocytes: karyotype/phenotype correlations. Prenat Diagn. 2015 Sep;35(9):841-7. doi: 10.1002/pd.4620. Epub 2015 Jun 23.
• Victor AR, Tyndall JC, Brake AJ, Lepkowsky LT, Murphy AE, Griffin DK, McCoy RC, Barnes FL, Zouves CG, Viotti M. One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies. Fertil Steril. 2019 Feb;111(2):280-293. doi: 10.1016/j.fertnstert.2018.10.019.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: Mosaic (ArQule)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No