Clinical trial NCT06353880: Obesity With Sperm Quality in Men With Fertility Need
Official title: Effects of Different Types of Obesity on Sperm Quality: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sperm Quality
Obesity
Sex Hormones
Visceral Fat
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will employ a cross-sectional design to recruit participants from a single Reproductive Center at the First Hospital of Jilin University. 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.

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 (e.g., 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

Eligibility criteria: Inclusion Criteria:

* Male individuals with fertility needs
* 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.
* Participants currently undergoing treatment for infertility or with a history of recent exposure to factors known to affect sperm quality (e.g., chemotherapy, radiation therapy).

Primary outcomes:
measure: Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors
timeFrame: This is a cross-sectional observation study, assessments will be conducted at baseline.
Secondary outcomes:
measure: Comparison of Sperm Quality Across BMI Categories and Testicular Fat-Wrapped Subgroups
timeFrame: This is a cross-sectional observation study, assessments will be conducted at baseline.
measure: Comparison of Sex Hormone Levels Across BMI Categories and Testicular Fat-Wrapped Subgroups
timeFrame: This is a cross-sectional observation study, assessments will be conducted at baseline.
Other outcomes:
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