Male Infertility Due to AzoospermiaAPHRNCT06911840
Male Factor Infertility Across India Using Aphrodite Criteria
An observational study of Male Infertility Due to Azoospermia, run by Indira IVF Hospital Pvt Ltd at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility Due to Azoospermia
- How many people
- 1,090 participants
- Where
- 1 siteIndia
- Study dates
- 23 Jan 2026to 23 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All male visiting IVF clinics across different centres
Who may be able to join
- All male visiting IVF clinic willingly giving consent for andrological evaluation.
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Indira IVF Hospital
Udaipur, Rajasthan, 313001
Vipin Chandra, DGO, +91 9567971239, drvipinchandra@indiraivf.in
Sandro Esteves, MD,PhD
About this study
Official title: 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.
Read more
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
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Male infertility, Azoospermia, Aphrodite criteria, Prevelance
- Medical subject headings
- Infertility, Male, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | All the male population visiting IVF centre Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of male infertility across the country
Overall prevalence of male infertility according to the Aphrodite criteria in India.
Measured: 6 months
Secondary outcomes (2)
Prevalence of male infertility across various geographical distribution
Prevalence of male infertility according to the Aphrodite criteria in different regions of India.
Measured: 6 months
Factors associated with male infertility
Factors associated with male infertility according to the Aphrodite criteria, both overall and stratified by region
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start23 Jan 2026 (estimated)
- Primary completion23 Jun 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Male Infertility Due to AzoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,090 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indira IVF Hospital Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911840
- Sponsor's protocol ID
- IIHL/UDR/P/02_2024
- Acronym
- APHR
- Status last verified
- Jan 2026
- First submitted
- 28 Mar 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 33790862May 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.
PubMed 9230450Esteves 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.
PubMed 38367592
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Male Factor Infertility Across India: An Observational Cross-Sectional Study Using the Aphrodite Criteria, a Hospital-based Study
- ClinicalTrials.gov ID
- NCT06911840
- Acronym / sponsor ID
- APHR / IIHL/UDR/P/02_2024
- Conditions
- Male Infertility Due to Azoospermia
- Keywords
- Male infertility, Azoospermia, Aphrodite criteria, Prevelance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,090 participants (estimated)
- Lead sponsor
- Indira IVF Hospital Pvt LtdUniversity, hospital or other
- Study start
- 23 Jan 2026 (estimated)
- Primary completion
- 23 Jun 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No Intervention: Observational CohortAll the male population visiting IVF centre |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All male visiting IVF clinics across different centres
Key inclusion criteria (1 listed)
- All male visiting IVF clinic willingly giving consent for andrological evaluation.
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | Group 1 |
Primary outcome
Prevalence of male infertility across the country
Time frame: 6 months
Overall prevalence of male infertility according to the Aphrodite criteria in India.
2 secondary outcomes
Prevalence of male infertility across various geographical distribution
Time frame: 6 months
Factors associated with male infertility
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Results publication: PubMed 33790862Esteves 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.
- Results publication: PubMed 9230450May 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.
- Results publication: PubMed 38367592Esteves 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.
- Individual participant dataSharing planned: 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.
Related trials for Male Infertility Due to Azoospermia
Active, not recruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Infertility Due to Azoospermia, Infertility, Male
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
Enrolling by invitationPhase 2
Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm
Oligospermia, Azoospermia, Nonobstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility Due to Azoospermia, run by Indira IVF Hospital Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vipin Chandra, DGO (+91- 9567971239, ifa@indiraivf.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of male infertility across the country (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06911840, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.