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NCT05936749 Clinical Trial

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

Genetic Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05936749
Other study ID # 14/23
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2016
Est. completion date December 12, 2022

Study information
Verified date June 2023
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date December 12, 2022
Est. primary completion date December 12, 2022
Accepts healthy volunteers
Gender Female
Age group 34 Years to 42 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• Pre-implantation genetic testing

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Istituto Clinico Humanitas

Outcome
Type Measure Description Time frame Safety issue
Primary Live birth rate (LBR) LBR will be measured as a percentage 7 years of inclusion
Primary Cumulative live birth rate (CLBR) per couple CLBR per couple will be measured as a percentage 7 years of inclusion
Primary Abortion rate (AR) AR will be measured as a percentage 7 years of inclusion
Secondary Aneuploidy Aneuploidy embryo rate will be measured as a percentage 7 years of inclusion
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