A Prospective Study of a Mosaic Embryo Transfer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transfer of mosaic embryo.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Transfer of mosaic embryo
Subjects will transfer a mosaic embryo transferred to their uterus
Primary outcome measures
- Evaluation of Implantation rate [Time frame: 3-4 weeks after embryo transfer]
- Live birth rate [Time frame: 9-12 months post embryo transfer]
Secondary outcome measures (6)
- Miscarriage Rates [Time frame: 5-12 months post embryo transfer]
- Products of conception from miscarriage [Time frame: 2-9 months post embryo transfer]
- Pregnancy complications [Time frame: 9-12 months post embryo transfer]
- Stillbirth rates associated with Mosaic Embryo Transfer [Time frame: 9-12 months post embryo transfer]
- Prenatal testing [Time frame: 9-12 months post embryo transfer]
- Neonatal Outcomes [Time frame: 12-15 months after birth of baby]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Colorado Center for Reproductive Medicine — Lone Tree
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. PMID 25976239
- 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
Identifiers
NCT: NCT04472156 · Mosaic