Clinical trial NCT06911840: Male Factor Infertility Across India Using Aphrodite Criteria
Official title: Assessment of Male Factor Infertility Across India: An Observational Cross-Sectional Study Using the Aphrodite Criteria, a Hospital-based Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Male Infertility Due to Azoospermia
Keywords: Male infertility
Azoospermia
Aphrodite criteria
Prevelance
Lead sponsor: Indira IVF Hospital Pvt Ltd
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 1090
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All male visiting IVF clinics across different centres

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Prevalence of male infertility across the country
timeFrame: 6 months
Secondary outcomes:
measure: Prevalence of male infertility across various geographical distribution
timeFrame: 6 months
measure: Factors associated with male infertility
timeFrame: 6 months
Other outcomes:
Locations:
city: Udaipur
country: India
facility: Indira IVF Hospital
state: Rajasthan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.