Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06358794
Other study ID # IRB00006761-M2022692
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date May 31, 2023

Study information

Verified date April 2024
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 2612
Est. completion date May 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - diagnosed with nonobstructive azoospermia - underwent microdissection testicular sperm extraction Exclusion Criteria: - without intact clinical information - low data quality

Study Design


Intervention

Diagnostic Test:
Machine learning-based predictive model
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.

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary SRR of micro-TESE the sperm retrieval success rate of microdissection testicular sperm extraction At the time after microdissection testicular sperm extraction
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04142112 - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation N/A
Recruiting NCT04955782 - Abstinence Period and Semen Quality
Recruiting NCT05506722 - Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity N/A
Not yet recruiting NCT03988361 - Selection of Non Apoptotic Human Sperm for in Vitro Fertilization by Using Magnetic Activated Cell Sorting (MACS)
Completed NCT03319654 - Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle N/A
Not yet recruiting NCT05597631 - G-IVF and Sperm Parameters N/A
Completed NCT05919186 - Effects of Antioxidant Supplementation of Culture Media on IVF Embryos N/A
Recruiting NCT03588949 - Role of Nutritional Support in Idiopathic Male Infertility N/A
Recruiting NCT03527043 - Impact of Escitalopram on Sperm DNA Fragmentation Phase 2
Completed NCT02932865 - Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility
Completed NCT02310087 - Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures N/A
Completed NCT00385346 - Expressive Writing in Male Infertility N/A
Completed NCT04509583 - The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation N/A
Recruiting NCT04144244 - Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles N/A
Recruiting NCT04452305 - Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting N/A
Completed NCT05461079 - Sperm Phenotype and Differentially Methylated Regions
Recruiting NCT05205733 - Expanding Fertility Care to Poor and Low Resourced Settings Study N/A
Completed NCT03960229 - The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor N/A
Not yet recruiting NCT06050031 - Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility
Not yet recruiting NCT03090438 - IVF Outcomes After Varicocele Repair N/A