Male Factor Infertility Across India Using Aphrodite Criteria

Официальное название

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

Обзор

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.

Вмешательства

• Другое No Intervention: Observational Cohort
  No intervention

Первичные конечные точки

• Prevalence of male infertility across the country [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Prevalence of male infertility across various geographical distribution [Срок оценки: 6 months]
• Factors associated with male infertility [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

• NONE

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Индия · 1 центр

• Indira IVF Hospital — Udaipur

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT06911840 · IIHL/UDR/P/02_2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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