Effect of Probiotics on Sperm Quality in Male Infertility Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Sperm Concentration Assessed by Computer-Aided Sperm Analysis (CASA)
研究概览
简要总结
This randomized, placebo-controlled pilot study aims to evaluate the effects of probiotic supplementation on sperm quality in male patients diagnosed with infertility. Male infertility accounts for approximately 40% of all infertility cases and is closely related to abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, inflammation, and DNA fragmentation are known to impact sperm function and subsequent fertilization potential negatively.
Probiotics are microorganisms that confer health benefits by improving the intestinal microenvironment and regulating immunity. Emerging research suggests that probiotics may reduce oxidative stress and DNA fragmentation in men with asthenozoospermia; however, clinical data on human sperm remains limited. This study seeks to determine whether specific probiotic strains can improve sperm parameters and function in patients with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia.
The study will enroll 60 male participants aged 20 to 45 who meet specific inclusion criteria, including a sperm concentration of less than 50 million/mL, motility less than 40%, and normal morphology (Kruger) less than 4%. Participants will be randomly assigned to either an experimental group receiving probiotics or a control group receiving a placebo for approximately 100 days.
Semen samples will be collected and analyzed at three time points: before the intervention (Day 0), during the intervention (Day 60), and at the end of the study (Day 100). The primary objective is to assess changes in sperm concentration, motility, and morphology using the Computer-Aided Sperm Analysis (CASA) system. Secondary objectives include evaluating sperm DNA integrity using the Sperm Chromatin Structure Assay (SCSA) by flow cytometry and assessing sperm function via the acrosome reaction assay. The results of this pilot study will help determine the potential therapeutic role of probiotics in the management of male infertility.
详细描述
Content: Male infertility accounts for approximately 40% of infertility cases and is often characterized by abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, environmental hormones, and inflammation can lead to sperm DNA fragmentation and mitochondrial dysfunction, ultimately affecting fertilization potential. While probiotics are known to improve gut microbiome balance and regulate immunity, limited studies suggest they may also improve sperm motility and reduce DNA fragmentation in men with asthenozoospermia.
This pilot study employs a randomized, placebo-controlled design to evaluate the efficacy of probiotic supplementation in improving sperm quality. A total of 60 male participants with unexplained infertility (specifically oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia) will be recruited. Participants will be divided into two groups: an experimental group receiving probiotics and a control group receiving a placebo.
The study duration for each participant is approximately 100 days, with semen samples collected at three distinct time points:
- Day 0 (Start Test): Baseline sample collection.
- Day 60 (Mid Test): Interim sample collection.
- Day 100 (Final Test): Post-intervention sample collection.
Semen analysis will be conducted using the following methodologies:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The control group receives a placebo identical in dosage form and appearance to the probiotic supplement, to ensure masking of participants and investigators.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 20 to 45 years
- •Diagnosis of unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia
- •Sperm concentration < 5 x 10^6/mL
- •Sperm total motility < 40%
- •Sperm morphology (Kruger strict criteria) < 4%
排除标准
- •History of hormonal disorders or epididymo-orchitis
- •Substance abuse, including drugs or excessive alcohol consumption
- •Diabetes mellitus
- •Kidney disease (defined as a doubling of creatinine levels or more)
- •Chronic liver disease
- •Varicocele
- •Current use of medications that interfere with hormones
- •Occupational or environmental exposure to pesticides, heavy metals, or solvents
- •Intake of antioxidant supplements within the past three months
- •Body Mass Index (BMI) of 30 kg/m^2 or higher
结局指标
主要结局
Change From Baseline in Sperm Concentration Assessed by Computer-Aided Sperm Analysis (CASA)
时间窗: Day 60, Day 100
Sperm concentration (million/mL) will be measured using the Computer-Aided Sperm Analysis (CASA) system. The change from Baseline (Day 0) to subsequent time points will be calculated.
Change From Baseline in Total Sperm Motility Percentage Assessed by Computer-Aided Sperm Analysis (CASA)
时间窗: Day 60, Day 100
The percentage of total motile sperm will be measured using the Computer-Aided Sperm Analysis (CASA) system. The change from Baseline (Day 0) to subsequent time points will be calculated.
Change From Baseline in Percentage of Normal Sperm Morphology Assessed by Computer-Aided Sperm Analysis (CASA)
时间窗: Day 60, Day 100
The percentage of sperm with normal morphology will be measured based on Kruger strict criteria using the Computer-Aided Sperm Analysis (CASA) system. The change from Baseline (Day 0) will be calculated.
次要结局
- Change From Baseline in Sperm DNA Fragmentation Index (DFI) Assessed by SCSA(Day 60, Day 100)
- Change From Baseline in Sperm Acrosome Reaction Rate Assessed by PNA Staining(Day 60, Day 100)