A Prospective Study of a Mosaic Embryo Transfer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Study of a Mosaic Embryo Transfer

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Transfer of mosaic embryo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Outcomes will be evaluated with women who have a mosaic embryo transferred
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transfer of mosaic embryo<br>Women will have a mosaic embryo transferred to their uterus after in vitro fertilization (IVF) with pre implantation genetic testing completed at Colorado Center for Reproductive Medicine. | Procedure: Transfer of mosaic embryo<br>* Subjects will transfer a mosaic embryo transferred to their uterus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3-4 weeks after embryo transfer | 
| Live birth rate | Live birth rate will be evaluated | 9-12 months post embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage Rates | The rate of miscarriage will be evaluated associated with a mosaic embryo transfer | 5-12 months post embryo transfer | 
| 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. | 2-9 months post embryo transfer | 
| 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 | 9-12 months post embryo transfer | 
| Stillbirth rates associated with Mosaic Embryo Transfer | The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer | 9-12 months post embryo transfer | 
| Prenatal testing | If available, we will request any results of prenatal testing of karyotype that was obtained via Amniocentesis or Chorionic Villa Sampling (CVS) | 9-12 months post embryo transfer | 
| Neonatal Outcomes | Patient will be contacted to assess the health of the infant, noting any medical problems if any that the baby has. | 12-15 months after birth of baby |