Male Factor Infertility Across India Using Aphrodite Criteria (APHR)

January 23, 2026 updated by: Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1090

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vipin Chandra, DGO
  • Phone Number: +91- 9567971239
  • Email: ifa@indiraivf.in

Study Locations

  • India
    • Rajasthan
      • Udaipur, Rajasthan, India, 313001
        • Indira IVF Hospital
        • Sub-Investigator:
          • Shyam Gupta, MD
        • Sub-Investigator:
          • Akanksha Jangid, MD
        • Contact:
        • Sub-Investigator:
          • Pawan Yadav, MD
        • Sub-Investigator:
          • Nisha Tiwari, DNB
        • Sub-Investigator:
          • Amol Lunkad, MD
        • Sub-Investigator:
          • Rinoy Sreedharan, MD
        • Sub-Investigator:
          • Sandro Esteves, MD,PhD
        • Sub-Investigator:
          • Taruna Jhambh, MD
        • Sub-Investigator:
          • Dayanidhi Kumar, MD
        • Sub-Investigator:
          • Nishtha Handa, MS
        • Sub-Investigator:
          • Tanu Batra, MD
        • Sub-Investigator:
          • Amol Naik, DNB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All male visiting IVF clinics across different centres

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • NONE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
All the male population visiting IVF centre
Other: No Intervention: Observational Cohort
No intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indira IVF Hospital Pvt Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 23, 2026

Primary Completion (Estimated)

June 23, 2026

Study Completion (Estimated)

October 23, 2026

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIHL/UDR/P/02_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publication of the study and on request

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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