- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06454058
Association Between Euploid Embryo Grade and Maternal Age
Association Between Euploid Embryo Grade and Maternal Age, a Retrospective Cross-sectional Study
Background: Advanced maternal age (AMA) is associated with a reduction in live birth rate (LBR) after ART cycles. The main reason for this reduction is the lower number of oocytes aspirated, the number of developing embryos and the low number of euploid embryos available for transfer. The impact of age on success rates after the transfer of an euploid embryo has been a matter of discussion, with a recent meta-analysis showing a reduction in LBR after the transfer of an euploid blastocyst to women of AMA (1). There could be many reasons for this reduced LBR but they can be categorized into two broad categories - the uterus (including the mother's health) and the embryo (including the oocyte and the sperm).
It is possible that factors associated with reduced embryo quality would manifest in a lower embryo grade.
Study Overview
Status
Conditions
Detailed Description
Objective: To study if there is an association between advanced maternal age and lower embryo grading of euploid embryos.
Hypothesis: Advanced maternal age is associated with a lower embryonic grade in euploid embryos.
Study Design: This is a retrospective cross-sectional study of euploid embryos from patients who have completed IVF with PGT-A testing at a fertility clinic in The Prelude Network (US sites only). A comparison of embryo grade between different age groups (<35, 40+) will be done after controlling for baseline demographic characteristics.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77081
- Inception Fertility Research Institute, LLC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU)
- PGT biopsy was conducted in 2023,
- PGT biopsy was performed on blastocyst stage embryo,
- PGT-A result is euploid.
Exclusion Criteria:
- PGT-A result is mosaic,
- Embryos in which PGT-M was done and were found to be carriers of the mutation,
- Embryos in which PGT-SR was done and were found to be carriers of the structural rearrangement.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Embryo Grade
Time Frame: 6 months
|
Embryo grade for PGT-A confirmed euploid embryos
|
6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- INC-IIS-2024-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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