CTRI/2026/02/103510尚未招募不适用
Comparative Evaluation of the Hypo Osmotic Swelling Test, Modified HOS Test, and Water Test for assessing Sperm Membrane Integrity and Viability with Grading of Tail Swelling patterns in subfertile men
Saveetha institute of Medical and Technical Sciences,(SIMATS)1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study aims to compare different laboratory based tests used to assess sperm membrane integrity and viability in subfertile men. Semen samples will be collected as part of routine semen analysis and evaluated using hypo osmotic swelling test modified hypo osmotic swelling test and water test. The proportion of spermatozoa showing intact membrane integrity and viable spermatozoa will be recorded. Tail swelling patterns will be graded and compared among the three tests. The findings of this study may help identify the most reliable laboratory method for assessing sperm membrane integrity and viability in subfertile men.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male partners of subfertile couples Men presenting with primary or secondary infertility (failure to conceive after 12 months of regular unprotected intercourse).
- •2.Age group Men aged 18 to 50 years representing the reproductive age group.
- •Semen samples for analysis Fresh ejaculated semen samples were obtained by masturbation after 2 to 7 days of sexual abstinence.
- •Subfertile semen profiles Samples showing one or more abnormal semen parameters according to WHO semen analysis criteria (asthenozoospermia, oligozoospermia, teratozoospermia, or mixed abnormalities).
- •Adequate sperm concentration Samples with sufficient sperm count to perform HOS test, modified HOS test, and water test, and allow evaluation of tail swelling patterns.
- •Informed consent Participants who are willing to provide written informed consent for inclusion in the study.
- •A male undergoing infertility evaluation, especially with abnormal semen parameters.
排除标准
- •1.Normozoospermic fertile men Men with proven fertility or normal semen parameters undergoing evaluation for non infertility related reasons.
- •2.Azoospermia Complete absence of sperm in the ejaculate.
- •3.Severe systemic or reproductive pathology Known genetic abnormalities (Klinefelter syndrome), untreated endocrine disorders, or testicular malignancy.
- •4.Active genital tract infection Presence of leukocytospermia, sexually transmitted infections, or acute inflammation at the time of semen analysis.
- •5.Recent febrile illness or gonadotoxic exposure History of fever (more than 38 degree celsius), chemotherapy, radiotherapy, or exposure to gonadotoxic drugs within the previous 3 months.
- •6.Samples with excessive debris or necrozoospermia Samples unsuitable for accurate membrane integrity or tail swelling pattern assessment.
- •7.Use of donor semen or surgically retrieved sperm Epididymal or testicular sperm samples excluded to maintain methodological uniformity.
- •8.Improper sample collection or handling Inadequate semen volume, Incomplete ejaculation, prolonged liquefaction time, or samples processed beyond acceptable time limits.
研究者
Ammu Chandhini A
Saveetha institute of Medical and Technical Sciences Sciences ( SIMATS)
研究点 (1)
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