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OpenTrials
Completed

NCT Number: NCT05936749

Pre-implantation Genetic Testing for Monogenic Disease: Single Center Experience

This monocentric retrospective observational study aims to evaluate the efficacy of pre-implantation genetic testing for monogenic diseases (PGT-M). The effectiveness will be assessed in terms of live birth rate (LBR), cumulative live birth rate (CLBR) per couple, and abortion rate (AR). Considering how many cycles the participants have undergone to achieve a viable blastocyst. The secondary objective is to evaluate the incidence of aneuploidy in unaffected embryos, in order to understand the need for pre-implantation genetic testing for aneuploidy (PGT-A)in addition to PGT-M.

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Key information

Conditions

Genetic Disease Aneuploidy Chromosome Aberrations Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

34 year–42 year

Sex eligibility

Female

Study type

Observational

Who can participate

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

Inclusion criteria

  • Patients fertile or infertile that have undergone preimplantation genetic testing for monogenic diseases (PGTM).

Exclusion criteria

  • No exclusion criteria will be taken into consideration.

Treatment and study plan

Pre-implantation genetic testing

Genetic

Primary outcomes

  1. Live birth rate (LBR)

    Time frame: 7 years of inclusion

    LBR will be measured as a percentage

  2. Cumulative live birth rate (CLBR) per couple

    Time frame: 7 years of inclusion

    CLBR per couple will be measured as a percentage

  3. Abortion rate (AR)

    Time frame: 7 years of inclusion

    AR will be measured as a percentage

Secondary outcomes

  1. Aneuploidy

    Time frame: 7 years of inclusion

    Aneuploidy embryo rate will be measured as a percentage

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

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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