Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124, United States
Location status: Recruiting
NCT Number: NCT04472156
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).
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Lone Tree, Colorado, 80124, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will transfer a mosaic embryo transferred to their uterus
Time frame: 3-4 weeks after embryo transfer
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
Time frame: 9-12 months post embryo transfer
Live birth rate will be evaluated
Time frame: 5-12 months post embryo transfer
The rate of miscarriage will be evaluated associated with a mosaic embryo transfer
Time frame: 2-9 months post embryo transfer
Products of conception will be karyotyped if available following a miscarriage and compared to that of previous PGT testing if the patient is willing to have the testing.
Time frame: 9-12 months post embryo transfer
Patient will be evaluated after delivery to assess if patient had any complications associated with the pregnancy. This will be completed with telephone interview
Time frame: 9-12 months post embryo transfer
The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer
Time frame: 9-12 months post embryo transfer
If available, we will request any results of prenatal testing of karyotype that was obtained via Amniocentesis or Chorionic Villa Sampling (CVS)
Time frame: 12-15 months after birth of baby
Patient will be contacted to assess the health of the infant, noting any medical problems if any that the baby has.
Contact information is provided by the study sponsor or research team.
Colorado Center for Reproductive Medicine
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07226310
Genital Diseases, Infertility
Oklahoma City, Oklahoma, United States
View Trial DetailsNCT05440617
Acute Ovarian Failure, Early Menopause And Infertility In Females After Treatment For Childhood Cancer
Bethesda, Maryland, United States
View Trial DetailsNCT01500447
Amenorrhea, Congenital Abnormalities
Bethesda, Maryland, United States
View Trial DetailsNCT07340827
Genital Diseases, Infertility
Akita, Japan
View Trial Details