An observational study in Male Infertility Due to Azoospermia, sponsored by Indira IVF Hospital Pvt Ltd. Not yet recruiting at 1 site in India. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Indira IVF Hospital Pvt Ltd · Observational
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.
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's planned enrollment of 1,090 is above the median of 95 across 24 observational studies indexed under Azoospermia.
Browse Azoospermia studies →Indira IVF Hospital Pvt Ltd is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Compared within Azoospermia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infertility, Male. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All male visiting IVF clinics across different centres
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All the male population visiting IVF centre
Other: No Intervention: Observational Cohort
No intervention
Prevalence of male infertility across the country
Overall prevalence of male infertility according to the Aphrodite criteria in India.
Time frame: 6 months
Prevalence of male infertility across various geographical distribution
Prevalence of male infertility according to the Aphrodite criteria in different regions of India.
Time frame: 6 months
Factors associated with male infertility
Factors associated with male infertility according to the Aphrodite criteria, both overall and stratified by region
Time frame: 6 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Indira IVF Hospital Pvt Ltd