A Prospective Study of a Mosaic Embryo Transfer

NCT04472156 | Recruiting

• 1 other identifier: Mosaic
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Miscarriage Rates

  5-12 months post embryo transfer

• Products of conception from miscarriage

  2-9 months post embryo transfer

• Pregnancy complications

  9-12 months post embryo transfer

• Stillbirth rates associated with Mosaic Embryo Transfer

  9-12 months post embryo transfer

• Prenatal testing

  9-12 months post embryo transfer

Study Arms (1)

Transfer of mosaic embryo

EXPERIMENTAL

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

Interventions

Transfer of mosaic embryo PROCEDURE

Subjects will transfer a mosaic embryo transferred to their uterus

Transfer of mosaic embryo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado Center for Reproductive Medicine: lead

Study Sites (1)

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, 80124, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 25976239 BACKGROUND

• 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.

  PMID: 30691630 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Mandy Katz-Jaffe, PhD

  Fertility Genetics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Makloski, RN

CONTACT

303-788-8300; rmakloski@colocrm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific and Genetics Director

Model Details: Outcomes will be evaluated with women who have a mosaic embryo transferred

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 15, 2020
• Study Start: October 15, 2020
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)