Male Factor Infertility Across India Using Aphrodite Criteria

Assessment of Male Factor Infertility Across India: An Observational Cross-Sectional Study Using the Aphrodite Criteria, a Hospital-based Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06911840

Acronym

APHR

Enrollment

1090

Registered

2025-04-04

Start date

2026-01-23

Completion date

2026-10-23

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility Due to Azoospermia

Keywords

Male infertility, Azoospermia, Aphrodite criteria, Prevelance

Brief summary

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.

Interventions

OTHERNo Intervention: Observational Cohort

No intervention

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

MALE

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* NONE

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of male infertility across the country	6 months	Overall prevalence of male infertility according to the Aphrodite criteria in India.

Secondary

Measure	Time frame	Description
Prevalence of male infertility across various geographical distribution	6 months	Prevalence of male infertility according to the Aphrodite criteria in different regions of India.
Factors associated with male infertility	6 months	Factors associated with male infertility according to the Aphrodite criteria, both overall and stratified by region

Countries

India

Contacts

CONTACTVipin Chandra, DGO

ifa@indiraivf.in+91- 9567971239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026