Male Factor Infertility Across India Using Aphrodite Criteria

NCT06911840 | Not Yet Recruiting DMC

• 1 other identifier: IIHL/UDR/P/02_2024
• Study Type: observational
• Target: 1,090
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility Due to Azoospermia

Keywords

Male infertility; Azoospermia; Aphrodite criteria; Prevelance

Outcome Measures

Primary Outcomes (1)

• Prevalence of male infertility across the country

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

  6 months

Secondary Outcomes (2)

• Prevalence of male infertility across various geographical distribution

  6 months

• Factors associated with male infertility

  6 months

Study Arms (1)

Group 1

All the male population visiting IVF centre

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention

Group 1

Eligibility Criteria

• Gender Eligibility Details: Male attending IVF Clinic
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All male visiting IVF clinics across different centres

You may qualify if:

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

You may not qualify if:

• NONE

Sponsors & Collaborators

• Indira IVF Hospital Pvt Ltd: lead

Study Sites (1)

Indira IVF Hospital

Udaipur, Rajasthan, 313001, India

Location

Related Publications (3)

• Esteves SC, Yarali H, Vuong LN, Carvalho JF, Ozbek IY, Polat M, Le HL, Pham TD, Ho TM. Low Prognosis by the POSEIDON Criteria in Women Undergoing Assisted Reproductive Technology: A Multicenter and Multinational Prevalence Study of Over 13,000 Patients. Front Endocrinol (Lausanne). 2021 Mar 12;12:630550. doi: 10.3389/fendo.2021.630550. eCollection 2021.

  PMID: 33790862 RESULT

• May WL, Johnson WD. A SAS macro for constructing simultaneous confidence intervals for multinomial proportions. Comput Methods Programs Biomed. 1997 Jul;53(3):153-62. doi: 10.1016/s0169-2607(97)01809-9.

  PMID: 9230450 RESULT

• Esteves SC, Humaidan P, Ubaldi FM, Alviggi C, Antonio L, Barratt CLR, Behre HM, Jorgensen N, Pacey AA, Simoni M, Santi D. APHRODITE criteria: addressing male patients with hypogonadism and/or infertility owing to altered idiopathic testicular function. Reprod Biomed Online. 2024 Apr;48(4):103647. doi: 10.1016/j.rbmo.2023.103647. Epub 2023 Oct 29.

  PMID: 38367592 RESULT

MeSH Terms

Conditions

Infertility, Male; Azoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Central Study Contacts

Vipin Chandra, DGO

CONTACT

+91- 9567971239; ifa@indiraivf.in

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Clinical Lab Operations

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the study and on request
• 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

Locations

IN (1)