Infertility
Conditions
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.
Interventions
PROCEDURETransfer of mosaic embryo
Subjects will transfer a mosaic embryo transferred to their uterus
Sponsors
Colorado Center for Reproductive Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Outcomes will be evaluated with women who have a mosaic embryo transferred
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Implantation rate | 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 |
| Live birth rate | 9-12 months post embryo transfer | Live birth rate will be evaluated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy complications | 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 |
| Stillbirth rates associated with Mosaic Embryo Transfer | 9-12 months post embryo transfer | The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer |
| Miscarriage Rates | 5-12 months post embryo transfer | The rate of miscarriage will be evaluated associated with a mosaic embryo transfer |
| Neonatal Outcomes | 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. |
| Prenatal testing | 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) |
| Products of conception from miscarriage | 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. |
Countries
United States
Contacts
Primary ContactRachel Makloski, RN
Outcome results
None listed