Clinical trial NCT04472156: A Prospective Study of a Mosaic Embryo Transfer
Official title: A Prospective Study of a Mosaic Embryo Transfer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Colorado Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Outcomes will be evaluated with women who have a mosaic embryo transferred
Primary purpose: TREATMENT

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).

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.

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.

Primary outcomes:
measure: Evaluation of Implantation rate
timeFrame: 3-4 weeks after embryo transfer
measure: Live birth rate
timeFrame: 9-12 months post embryo transfer
Secondary outcomes:
measure: Miscarriage Rates
timeFrame: 5-12 months post embryo transfer
measure: Products of conception from miscarriage
timeFrame: 2-9 months post embryo transfer
measure: Pregnancy complications
timeFrame: 9-12 months post embryo transfer
measure: Stillbirth rates associated with Mosaic Embryo Transfer
timeFrame: 9-12 months post embryo transfer
measure: Prenatal testing
timeFrame: 9-12 months post embryo transfer
measure: Neonatal Outcomes
timeFrame: 12-15 months after birth of baby
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Colorado Center for Reproductive Medicine
state: Colorado
Study officials:
affiliation: Fertility Genetics
name: Mandy Katz-Jaffe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.