Male Factor Infertility Across India Using Aphrodite Criteria

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.

NCT Number	NCT06911840
Lead Sponsor	Indira IVF Hospital Pvt Ltd
Conditions	Male Infertility Due to Azoospermia
Enrollment	1,090 participants
Start Date	2026-01-23
Primary Completion	2026-06-23 (estimated)
Study Completion	2026-10-23 (estimated)
Updated on ClinicalTrials.gov	2026-01-26