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A study to compare different tests used to assess sperm survival and membrane health in subfertile men

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 - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/103510
Enrollment
50
Registered
2026-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N469- Male infertility, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Saveetha institute of Medical and Technical Sciences,(SIMATS)
Lead Sponsor

Eligibility

Inclusion criteria

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. 3. Semen samples for analysis Fresh ejaculated semen samples were obtained by masturbation after 2 to 7 days of sexual abstinence. 4. Subfertile semen profiles Samples showing one or more abnormal semen parameters according to WHO semen analysis criteria (asthenozoospermia, oligozoospermia, teratozoospermia, or mixed abnormalities). 5. 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. 6. 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

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.

Design outcomes

Primary

MeasureTime frame
Proportion of spermatozoa showing intact membrane integrity as assessed by hypo osmotic swelling test, modified hypo osmotic swelling test, and water testTimepoint: At the time of semen analysis

Secondary

MeasureTime frame
Comparison of sperm viability results obtained using hypo osmotic swelling test, modified hypo osmotic swelling test, water test and grading of tail swelling patternsTimepoint: At the time of semen analysis

Countries

India

Contacts

Public ContactDr Nidhi Sharma S

Saveetha institute of Medical and Technical Sciences

nidhisharma.smc@saveetha.com9445560392

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026