A Prospective Study of a Mosaic Embryo Transfer
ConditionInfertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorColorado Center for Reproductive Medicine
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transfer of mosaic embryo
Procedure/SurgerySubjects will transfer a mosaic embryo transferred to their uterus
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Transfer of mosaic embryoExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of Implantation rate
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
3-4 weeks after embryo transfer2
Live birth rate
Live birth rate will be evaluated
Time frame
9-12 months post embryo transferSecondary outcomes
1
Miscarriage Rates
The rate of miscarriage will be evaluated associated with a mosaic embryo transfer
Time frame
5-12 months post embryo transfer2
Products of conception from miscarriage
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
2-9 months post embryo transfer3
Pregnancy complications
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 transfer4
Stillbirth rates associated with Mosaic 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 transferSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov