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NCT Number: NCT06911840

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.

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Key information

Sex eligibility

Male

Study type

Observational

Primary location

Indira IVF Hospital

Udaipur, Rajasthan, 313001, India

Location contact

Akanksha Jangid, MD

SUB_INVESTIGATOR

Amol Lunkad, MD

SUB_INVESTIGATOR

Amol Naik, DNB

SUB_INVESTIGATOR

Dayanidhi Kumar, MD

SUB_INVESTIGATOR

Nisha Tiwari, DNB

SUB_INVESTIGATOR

Nishtha Handa, MS

SUB_INVESTIGATOR

Pawan Yadav, MD

SUB_INVESTIGATOR

Rinoy Sreedharan, MD

SUB_INVESTIGATOR

Sandro Esteves, MD,PhD

SUB_INVESTIGATOR

Shyam Gupta, MD

SUB_INVESTIGATOR

Tanu Batra, MD

SUB_INVESTIGATOR

Taruna Jhambh, MD

SUB_INVESTIGATOR

Vipin Chandra, DGO

CONTACT

[email protected]

+91 9567971239

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • NONE

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

Primary outcomes

  1. Prevalence of male infertility across the country

    Time frame: 6 months

    Overall prevalence of male infertility according to the Aphrodite criteria in India.

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Vipin Chandra, DGO

CONTACT

[email protected]

+91- 9567971239

Sponsors and collaborators

Lead sponsor

Indira IVF Hospital Pvt Ltd

Other

Registry information

Official study title

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

Acronym: APHR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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