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.

Inclusion Criteria:

• All male visiting IVF clinic willingly giving consent for andrological evaluation.

Exclusion Criteria:

• NONE

Male attending IVF Clinic

All male visiting IVF clinics across different centres

The following supporting information will be made available as part of the data sharing plan:

Study Protocol

Available upon request or publication of study results.

Statistical Analysis Plan (SAP)

Will be shared with interested parties upon completion of the study.

Informed Consent Form (ICF)

A copy of the ICF will be available upon request from participating sites.

Clinical Study Report (CSR)

The final CSR will be shared once the study results are finalized and published.

Analytic Code

Will be shared alongside the study results for transparency and reproducibility of the findings.

After publication of the study and on request

Academic researchers, clinicians, and scientists involved in related fields of study.

Regulatory Bodies: Organizations such as ethics committees, health authorities, and regulatory agencies that require access for monitoring and compliance purposes.

Collaborators and Partners: Institutions or organizations collaborating on the study, subject to agreements for data sharing and confidentiality.

What They Will Be Able to Access:

Study Protocol: Complete details regarding the study design, objectives, and methodology.

Statistical Analysis Plan (SAP): Full plan for data analysis, statistical methods, and handling of results.

Informed Consent Form (ICF): Document outlining the consent process and participant rights, shared with participating researchers and ethics boards.

Clinical Study Report (CSR): The final comprehensive report including all study findings, results, and conclusions.

Analytic Code: The code used for statistical analysis, available for validation and reproducibility