- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06358794
Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate
April 7, 2024 updated by: Peking University Third Hospital
SpermFinder: Machine Learning Based-Personalized Prediction of Sperm Retrieval in Patients With Nonobstructive Azoospermia Prior to Microdissection Testicular Sperm Extraction
Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility.
However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging.
The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients.
In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort).
The clinical features of participants were used to train, test and validate the machine learning models.
Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2612
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Peking University Third Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Nonobstructive azoospermia patients who underwent microdissection testicular sperm extraction at the Reproductive Center of Peking University Third Hospital were respectively enrolled.
Description
Inclusion Criteria:
- diagnosed with nonobstructive azoospermia
- underwent microdissection testicular sperm extraction
Exclusion Criteria:
- without intact clinical information
- low data quality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Training cohort
2,438 patients diagnosed with NOA were included for model training and validation
|
The clinical features of participants were used to train, test and validate the machine learning models.
Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models.
|
|
External validation cohort
174 participants from January 2023 to May 2023 were included as the external validation cohort for online platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SRR of micro-TESE
Time Frame: At the time after microdissection testicular sperm extraction
|
the sperm retrieval success rate of microdissection testicular sperm extraction
|
At the time after microdissection testicular sperm extraction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
April 7, 2024
First Submitted That Met QC Criteria
April 7, 2024
First Posted (Actual)
April 11, 2024
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 7, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00006761-M2022692
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The raw clinical data are not publicly available.
Processed nonsensitive data and analysis code are available from the corresponding author on reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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