A Prospective Study of a Mosaic Embryo Transfer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2026-12-15

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).

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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.

Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Outcomes will be evaluated with women who have a mosaic embryo transferred

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transfer of mosaic embryo

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.

Group Type EXPERIMENTAL

Transfer of mosaic embryo

Intervention Type PROCEDURE

Subjects will transfer a mosaic embryo transferred to their uterus

Interventions

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Transfer of mosaic embryo

Subjects will transfer a mosaic embryo transferred to their uterus

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes