CTRI/2026/02/103510Not yet recruitingNot Applicable
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 site in 1 country50 target enrollmentStarted: February 18, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
Ammu Chandhini A
Saveetha institute of Medical and Technical Sciences Sciences ( SIMATS)
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 2/3
Role of shalmali moola tablets to Increase sperm countCTRI/2024/07/071016G.J. Patel Institute Of Ayurvedic Studies and Research100
Completed
Not Applicable
24-Hour Semen Survival Rate Post-IUI for Pregnancy OutcomesCTRI/2024/11/076578A.Rajesh kumar250
Not yet recruiting
Not Applicable
Development of a 3D printed Microfluidic Sperm Sorting Chamber For Enhanced Reproductive SuccessCTRI/2025/02/080360Dr kalpana L100
Not yet recruiting
Not Applicable
Comparing Swim-Up and Density Gradient Methods for Sperm Preparation Effects on Quality and Oxidative StressCTRI/2026/02/103414Saveetha Institute of Medical and Technical Sciences30
Recruiting
Not Applicable
Male Experiences With Intra Cytoplasmic Sperm Injection (ICSI) and Reduced Sperm QualityPsychological Experience in Fertility TreatmentHypogonadismTestosteron LevelsQuality of LifeSocial InteractionInfertile Males Comparied to Fertile MalesNCT07546435Peter Humaidan400