A Prospective Study of a Mosaic Embryo Transfer

Обзор

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).

Подробное описание

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.

Вмешательства

• Процедура Transfer of mosaic embryo
  Subjects will transfer a mosaic embryo transferred to their uterus

Первичные конечные точки

• Evaluation of Implantation rate [Срок оценки: 3-4 weeks after embryo transfer]
• Live birth rate [Срок оценки: 9-12 months post embryo transfer]

Вторичные конечные точки (6)

• Miscarriage Rates [Срок оценки: 5-12 months post embryo transfer]
• Products of conception from miscarriage [Срок оценки: 2-9 months post embryo transfer]
• Pregnancy complications [Срок оценки: 9-12 months post embryo transfer]
• Stillbirth rates associated with Mosaic Embryo Transfer [Срок оценки: 9-12 months post embryo transfer]
• Prenatal testing [Срок оценки: 9-12 months post embryo transfer]
• Neonatal Outcomes [Срок оценки: 12-15 months after birth of baby]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Colorado Center for Reproductive Medicine — Lone Tree

Публикации

• Wallerstein R, Misra S, Dugar RB, Alem M, Mazzoni R, Garabedian MJ. Current knowledge of prenatal diagnosis of mosaic autosomal trisomy in amniocytes: karyotype/phenotype correlations. Prenat Diagn. 2015 Sep;35(9):841-7. doi: 10.1002/pd.4620. Epub 2015 Jun 23. PMID 25976239
• Victor AR, Tyndall JC, Brake AJ, Lepkowsky LT, Murphy AE, Griffin DK, McCoy RC, Barnes FL, Zouves CG, Viotti M. One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies. Fertil Steril. 2019 Feb;111(2):280-293. doi: 10.1016/j.fertnstert.2018.10.019. PMID 30691630

Идентификаторы

NCT: NCT04472156 · Mosaic

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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