Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353880
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-31
Brief Title:
Obesity With Sperm Quality in Men With Fertility Need
Sponsor:
Yu xiaowei
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Effects of Different Types of Obesity on Sperm Quality A Cross-Sectional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the impact of different types of obesity on sperm quality Participants will be divided into three groups a normal BMI group an obese group without pudendal fat wrapping the testicles and an obese group with pudendal fat wrapping the testicles Sperm quality parameters will be compared among these groups to assess potential differences associated with different types of obesity
Detailed Description:
Background Obesity is a well-established risk factor for male infertility yet the mechanisms underlying this association remain incompletely understood Recent evidence suggests that the distribution of adipose tissue particularly pudendal fat deposition may have distinct effects on male reproductive health beyond overall body mass index BMI This cross-sectional study aims to elucidate the differential impact of various obesity types on sperm quality shedding light on potential pathways for intervention and treatment of male infertility
Objective The primary objective of this study is to compare sperm quality parameters among three distinct groups individuals with a normal BMI obese individuals without pudendal fat deposition around the testicles and obese individuals with pudendal fat deposition
Study Design This study will employ a cross-sectional design to recruit participants from insert recruitment settings Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition Sperm quality parameters including count motility and morphology will be assessed through semen analysis Additionally hormonal profiles related to reproductive health will be evaluated
Inclusion Criteria Male individuals with fertility needs with BMI within the specified ranges for normal weight and obesity will be eligible for participation Participants must provide informed consent prior to enrollment
Exclusion Criteria Individuals with known medical conditions affecting fertility such as cryptorchidism or primary testicular failure will be excluded from the study Participants currently undergoing treatment for infertility or with a history of recent exposure to factors known to affect sperm quality eg chemotherapy radiation therapy will also be excluded
Outcome Measures The primary outcome measure will be the comparison of sperm quality parameters count motility morphology among the three study groups Secondary outcome measures will include the evaluation of hormonal profiles related to reproductive health including levels of testosterone follicle-stimulating hormone FSH and luteinizing hormone LH
Sample Size Cross-sectional study ensures a large sample as far as possible with a minimum of more than 2000 participants
Statistical Analysis Descriptive statistics will be used to summarize demographic characteristics and outcome measures of interest Group comparisons will be performed using appropriate parametric or non-parametric statistical tests depending on the distribution of the data Multivariable regression analysis may be employed to adjust for potential confounding variables
Ethical Considerations This study will be conducted in accordance with the principles of the Declaration of Helsinki and local regulatory requirements Institutional Review Board IRB approval will be obtained prior to study initiation Informed consent will be obtained from all participants and measures will be taken to ensure confidentiality and privacy throughout the study
Data Collection and Management Data will be collected using standardized forms and entered into a secure electronic database Participant identifiers will be anonymized to protect confidentiality Data quality checks will be performed regularly to ensure accuracy and completeness
Study Duration The anticipated study duration is 12 mons Recruitment will commence upon IRB approval with data collection expected to be completed by 2024-6
Funding None
Principal Investigator Xiaowei Yu
Study Identifier 24K038-001
Objective The primary objective of this study is to compare sperm quality parameters among three distinct groups individuals with a normal BMI obese individuals without pudendal fat deposition around the testicles and obese individuals with pudendal fat deposition
Study Design This study will employ a cross-sectional design to recruit participants from insert recruitment settings Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition Sperm quality parameters including count motility and morphology will be assessed through semen analysis Additionally hormonal profiles related to reproductive health will be evaluated
Inclusion Criteria Male individuals with fertility needs with BMI within the specified ranges for normal weight and obesity will be eligible for participation Participants must provide informed consent prior to enrollment
Exclusion Criteria Individuals with known medical conditions affecting fertility such as cryptorchidism or primary testicular failure will be excluded from the study Participants currently undergoing treatment for infertility or with a history of recent exposure to factors known to affect sperm quality eg chemotherapy radiation therapy will also be excluded
Outcome Measures The primary outcome measure will be the comparison of sperm quality parameters count motility morphology among the three study groups Secondary outcome measures will include the evaluation of hormonal profiles related to reproductive health including levels of testosterone follicle-stimulating hormone FSH and luteinizing hormone LH
Sample Size Cross-sectional study ensures a large sample as far as possible with a minimum of more than 2000 participants
Statistical Analysis Descriptive statistics will be used to summarize demographic characteristics and outcome measures of interest Group comparisons will be performed using appropriate parametric or non-parametric statistical tests depending on the distribution of the data Multivariable regression analysis may be employed to adjust for potential confounding variables
Ethical Considerations This study will be conducted in accordance with the principles of the Declaration of Helsinki and local regulatory requirements Institutional Review Board IRB approval will be obtained prior to study initiation Informed consent will be obtained from all participants and measures will be taken to ensure confidentiality and privacy throughout the study
Data Collection and Management Data will be collected using standardized forms and entered into a secure electronic database Participant identifiers will be anonymized to protect confidentiality Data quality checks will be performed regularly to ensure accuracy and completeness
Study Duration The anticipated study duration is 12 mons Recruitment will commence upon IRB approval with data collection expected to be completed by 2024-6
Funding None
Principal Investigator Xiaowei Yu
Study Identifier 24K038-001
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None