Assessment of Male Factor Infertility Across India: An Observational Cross-Sectional Study Using the Aphrodite Criteria, a Hospital-based Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,090
- 试验地点
- 1
- 主要终点
- Prevalence of male infertility across the country
研究概览
简要总结
Study Purpose:
The purpose of this study is to conduct an observational cross-sectional analysis of male factor infertility across diverse regions of India utilizing the Aphrodite Criteria. This novel patient classification system offers a systematic approach to describing and managing male infertility, particularly for hypogonadal males with idiopathic infertility. The study aims to evaluate the current state of male fertility across India and identify any regional variations in male reproductive health and hypogonadism, which may be influenced by environmental, lifestyle, and genetic factors.
Study Objective:
The primary objective of this study is to conduct an observational cross-sectional analysis of male factor infertility across various regions of India using the Aphrodite Criteria. To reveal the prevalence and determinants of male factor infertility across different regions of India.
Hypothesis:
We hypothesize that there are significant regional differences in male factor infertility characteristics across India, with variations in sperm quality and testicular function due to diverse environmental, lifestyle, and genetic factors. Additionally, we hypothesize that the application of the Aphrodite Criteria will provide a more detailed classification of male infertility compared to conventional semen analysis and that certain lifestyle factors such as smoking, obesity, and occupational exposures will be associated with poorer sperm quality and testicular function.
Study Population:
The study population will consist of male patients visiting clinics across different IVF centers in India. The total sample size includes subjects from five groups with the following distribution:
35 subjects in Group I ; 416 subjects in Group II; 270 subjects in Group III; 152 subjects in Group IV; 216 subjects in Group V
The total sample size for all groups will be 1,090 subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All male visiting IVF clinic willingly giving consent for andrological evaluation.
排除标准
- 未提供
研究组 & 干预措施
Group 1
All the male population visiting IVF centre
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Prevalence of male infertility across the country
时间窗: 6 months
Overall prevalence of male infertility according to the Aphrodite criteria in India.
次要结局
- Prevalence of male infertility across various geographical distribution(6 months)
- Factors associated with male infertility(6 months)
研究者
Dr Vipin Chandra
Chief Clinical Lab Operations
Indira IVF Hospital Pvt Ltd