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/Actively Recruiting
Led by Colorado Center for Reproductive Medicine · Updated on 2024-02-29
250
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
A Prospective Study of a Mosaic Embryo Transfer
R
Rachel Makloski, RN
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Colorado Center for Reproductive Medicine
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Transfer of mosaic embryo (trial group) | Transfer of euploid embryo (current standard care) |
|---|---|---|
| What it is | Transfer of a mosaic embryo, identified by PGT after IVF, into the uterus of an eligible infertile woman. Mosaic embryos show a mix of normal and chromosome-altered cells. | Transfer of a genetically normal (euploid) embryo identified by PGT after IVF, which is the recommended and most common approach in reproductive medicine. |
| Role in trial | Only study arm. All enrolled participants undergo mosaic embryo transfer, monitored for implantation, pregnancy, and live birth outcomes. | Not included in trial. Provided here for context as the typical alternative for eligible patients with euploid embryos after IVF/PGT. |
| Primary use | Used for women who have only mosaic embryos remaining after IVF and PGT, and wish to attempt pregnancy without a euploid embryo. | Preferred for women with infertility who have at least one euploid embryo following IVF and PGT. Favored due to higher likelihood of successful pregnancy and lower risk of complications. |
| How it is given or performed | Embryo transfer procedure delivers the mosaic embryo into the uterus. Procedure follows standard IVF transfer protocol with added monitoring for potential chromosomal risks. | Genetically normal embryo (identified by PGT) is transferred into the uterus using standard IVF transfer protocol. Favored due to lower chromosomal risk. |
| Important limitations | Mosaic embryos carry chromosomal abnormalities which may increase the risks of implantation failure, miscarriage, or chromosomal anomalies in offspring. Outcomes are variable, and long-term safety is still being studied. | Euploid embryo transfer generally offers highest success rates, but some embryos may still fail to implant or result in miscarriage. Genetic testing is not always perfect, and risks of undetected abnormalities remain. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Robert Wallerstein, Sonya Misra, R Bryce Dugar...
https://pubmed.ncbi.nlm.nih.gov/25976239/Andrea R Victor, Jack C Tyndall, Alan J Brake...
https://pubmed.ncbi.nlm.nih.gov/30691630/Colorado Center for Reproductive Medicine
Lead Sponsor