Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID04472156

A Prospective Study of a Mosaic Embryo Transfer to Investigate Clinical Outcomes After IVF With Genetic Testing

Led by Colorado Center for Reproductive Medicine · Updated on 2024-02-29

250

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the outcomes after transferring a mosaic embryo, which contains both normal and abnormal chromosomal cells, in women undergoing in vitro fertilization (IVF) with preimplantation genetic testing (PGT). This prospective study aims to understand if transferring these embryos results in successful pregnancies and healthy live births, as some studies have suggested. The research focuses on implantation rates and live birth rates to determine if mosaic embryos should be routinely offered for transfer to patients experiencing infertility. Participants will undergo a single transfer of a mosaic embryo to the uterus after completing an IVF cycle with PGT at the Colorado Center for Reproductive Medicine. PGT involves testing a small number of cells from the embryo before transfer. Embryos identified as mosaic are usually not transferred as standard practice, but this study evaluates their potential for successful pregnancy. The study does not use a placebo or comparison group. Women in the study will be monitored through multiple follow-up periods after embryo transfer. Researchers will assess implantation rates 3 to 4 weeks after transfer and track live birth rates up to 9 to 12 months later. Additional outcomes include miscarriage rates, pregnancy complications, stillbirth rates, prenatal testing results, and neonatal outcomes up to 15 months after birth. Participants will have various clinical evaluations and tests as part of their routine care during the study period, which lasts up to about a year after embryo transfer.

CONDITIONS

Brief Title

A Prospective Study of a Mosaic Embryo Transfer

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 45
  • Infertile women who have completed an IVF cycle with preimplantation genetic testing at the Colorado Center for Reproductive Medicine
  • Patients can be of any race, culture, sexual orientation, or ethnicity
  • Patients who are willing to transfer a single embryo
Not Eligible

You will not qualify if you...

  • Patients who do not meet the clinical requirements for embryo transfer per clinic standards
  • Patients who desire more than a single embryo transfer
  • Patients using a gestational carrier
  • Embryonic mosaic PGT results that include chromosome errors 13, 18, or 21
  • Patients who did not complete their IVF with PGT cycle at the Colorado Center for Reproductive Medicine

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single event

Participants will have a mosaic embryo transferred to their uterus after IVF with preimplantation genetic testing.

1 visit (in-person) for embryo transfer

Follow-up

Duration - Up to 15 months after embryo transfer

Participants are monitored for implantation, pregnancy outcomes, and neonatal health after the embryo transfer.

Multiple visits including assessments at 3-4 weeks, 5-12 months, 9-12 months, and up to 12-15 months after birth

Trial Site Locations

Total: 1 location

1

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, United States, 80124

Actively Recruiting

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Research Team

R

Rachel Makloski, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Current knowledge of prenatal diagnosis of mosaic autosomal trisomy in amniocytes: karyotype/phenotype correlations.

Robert Wallerstein, Sonya Misra, R Bryce Dugar...

https://pubmed.ncbi.nlm.nih.gov/25976239

One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies.

Andrea R Victor, Jack C Tyndall, Alan J Brake...

https://pubmed.ncbi.nlm.nih.gov/30691630