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NCT Number: NCT04472156

A Prospective Study of a Mosaic Embryo Transfer

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).

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, 80124, United States

Location status: Recruiting

Location contact

Rachel Makloski, RN

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transfer of mosaic embryo

Procedure

Subjects will transfer a mosaic embryo transferred to their uterus

Primary outcomes

  1. Evaluation of Implantation rate

    Time frame: 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

  2. Live birth rate

    Time frame: 9-12 months post embryo transfer

    Live birth rate will be evaluated

Secondary outcomes

  1. Miscarriage Rates

    Time frame: 5-12 months post embryo transfer

    The rate of miscarriage will be evaluated associated with a mosaic embryo transfer

  2. Products of conception from miscarriage

    Time frame: 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.

  3. Pregnancy complications

    Time frame: 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

  4. Stillbirth rates associated with Mosaic Embryo Transfer

    Time frame: 9-12 months post embryo transfer

    The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer

  5. Prenatal testing

    Time frame: 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)

  6. Neonatal Outcomes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Makloski, RN

CONTACT

[email protected]

303-788-8300 ext. 1769

Sponsors and collaborators

Lead sponsor

Colorado Center for Reproductive Medicine

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2020
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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