Obesity With Sperm Quality in Men With Fertility Need

NCT06353880 | Not Yet Recruiting

• 1 other identifier: 24K08-001
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sperm Quality; Obesity; Sex Hormones; Visceral Fat

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  This is a cross-sectional observation study, assessments will be conducted at baseline.

Study Arms (3)

Normal BMI Group

Participants with a body mass index (BMI) within the normal range, without obesity-related fat accumulation around the testicles.

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.

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.

Other: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition.

Interventions

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.

Normal BMI Group; Obese with Pudendal Fat Group; Obese without Pudendal Fat Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men who with fertility need.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yu xiaowei: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 9, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04