Sperm QualityNCT06353880
Obesity With Sperm Quality in Men With Fertility Need
An observational study of Sperm Quality and Obesity, run by Yu xiaowei.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sperm Quality, Obesity, Sex Hormones
- What is being tested?
- Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition.
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Effects of Different Types of Obesity on Sperm Quality: A Cross-Sectional Study
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.
Read the 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
- Conditions
- Sperm Quality, Obesity, Sex Hormones, Visceral Fat
- Being tested
- Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal BMI Group | Participants with a body mass index (BMI) within the normal range, without obesity-related fat accumulation around the testicles. Receives: Other: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition. | |
| Obese without Pudendal Fat Group | Participants with obesity, characterized by excess adiposity, but without significant accumulation of fat around the testicles. Receives: Other: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition. | |
| Obese with Pudendal Fat Group | Participants with obesity and notable accumulation of fat around the testicles (pudendal fat), contributing to the study of its specific impact on sperm quality. Receives: Other: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors
Criteria for BMI Classification: Weight and height will be combined to report BMI in kg/m^2; Participants will be categorized into normal BMI (<25), obese BMI (≥30), and further subgrouped based on the presence or absence of notable accumulation of fat around the testicles.
Primary Outcome Measure: Incidence of notable accumulation of fat around the testicles in obese men; Exploration of potential risk factors including lifestyle factors (diet, exercise), comorbidities (diabetes, metabolic syndrome), hormonal imbalances, and genetic predispositions.
Measured: This is a cross-sectional observation study, assessments will be conducted at baseline.
Secondary outcomes (2)
Comparison of Sperm Quality Across BMI Categories and Testicular Fat-Wrapped Subgroups
Criteria for Comparison: Sperm quality parameters will be assessed using standardized methods, including sperm count, motility, morphology, and DNA integrity.
Outcome Measure: Differences in sperm quality between normal BMI participants, obese participants without testicular fat wrapping, and obese participants with testicular fat wrapping.
Measured: This is a cross-sectional observation study, assessments will be conducted at baseline.
Comparison of Sex Hormone Levels Across BMI Categories and Testicular Fat-Wrapped Subgroups
Criteria for Assessment: Serum levels of testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) will be measured.
Outcome Measure: Variations in sex hormone levels (testosterone, FSH, LH, E2) between normal BMI participants, obese participants without testicular fat wrapping, and obese participants with testicular fat wrapping.
Measured: This is a cross-sectional observation study, assessments will be conducted at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yu xiaowei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu xiaowei, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353880
- Sponsor's protocol ID
- 24K08-001
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The entirety of the data supporting article is accessible in textual format, figures, tables, and references. Upon request, additional breakdowns of this data will be promptly provided by the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Types of Obesity on Sperm Quality: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06353880
- Acronym / sponsor ID
- 24K08-001
- Conditions
- Sperm Quality, Obesity, Sex Hormones, Visceral Fat
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yu xiaoweiUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal BMI Group | – | Other: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition.Participants with a body mass index (BMI) within the normal range, without obesity-related fat accumulation around the testicles. |
| Obese without Pudendal Fat Group | – | Other: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition.Participants with obesity, characterized by excess adiposity, but without significant accumulation of fat around the testicles. |
| Obese with Pudendal Fat Group | – | Other: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition.Participants with obesity and notable accumulation of fat around the testicles (pudendal fat), contributing to the study of its specific impact on sperm quality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition.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. | Other | Normal BMI Group, Obese with Pudendal Fat Group, Obese without Pudendal Fat Group |
Primary outcome
Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors
Time frame: This is a cross-sectional observation study, assessments will be conducted at baseline.
Criteria for BMI Classification: Weight and height will be combined to report BMI in kg/m^2; Participants will be categorized into normal BMI (<25), obese BMI (≥30), and further subgrouped based on the presence or absence of notable accumulation of fat around the testicles. Primary Outcome Measure: Incidence of notable accumulation of fat around the testicles in obese men; Exploration of potential risk factors including lifestyle factors (diet, exercise), comorbidities (diabetes, metabolic syndrome), hormonal imbalances, and genetic predispositions.
2 secondary outcomes
Comparison of Sperm Quality Across BMI Categories and Testicular Fat-Wrapped Subgroups
Time frame: This is a cross-sectional observation study, assessments will be conducted at baseline.
Comparison of Sex Hormone Levels Across BMI Categories and Testicular Fat-Wrapped Subgroups
Time frame: This is a cross-sectional observation study, assessments will be conducted at baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided. The entirety of the data supporting article is accessible in textual format, figures, tables, and references. Upon request, additional breakdowns of this data will be promptly provided by the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sperm Quality and Obesity, run by Yu xiaowei.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors (time frame: This is a cross-sectional observation study, assessments will be conducted at baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.