| CTRI Number |
CTRI/2026/02/103510 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare different tests used to assess sperm survival and membrane health in subfertile men |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ammu Chandhini A |
| Designation |
Postgraduate |
| Affiliation |
Saveetha institute of Medical and Technical Sciences Sciences ( SIMATS) |
| Address |
Department of Clinical Embryology,
162, Poonamallee high road, Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9080688806 |
| Fax |
|
| Email |
chandhiniammu99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Sharma S |
| Designation |
Professor |
| Affiliation |
Saveetha institute of Medical and Technical Sciences |
| Address |
Department of Clinical Embryology, 162, Poonamallee high road, Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9445560392 |
| Fax |
91-44-26800892 |
| Email |
nidhisharma.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Sharma S |
| Designation |
Professor |
| Affiliation |
Saveetha institute of Medical and Technical Sciences |
| Address |
Department of Clinical Embryology, 162, Poonamallee high road, Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9445560392 |
| Fax |
91-44-26800892 |
| Email |
nidhisharma.smc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha institute of Medical and Technical Sciences,(SIMATS) |
| Address |
Saveetha Institute of Medical and Technical Sciences (SIMATS)
Saveetha Nagar, Thandalam, Chennai – 602105, Tamil Nadu, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Sharma |
Saveetha institute of Medical and Technical Sciences,(SIMATS) |
Department of Clinical Embryology, Saveetha Nagar, Thandalam, chennai - 602105
Chennai
TAMIL NADU |
9445560392
91-44-26800892
nidhisharma.smc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific review board, Saveetha Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N469||Male infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of spermatozoa showing intact membrane integrity as assessed by hypo osmotic swelling test, modified hypo osmotic swelling test, and water test |
At the time of semen analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of sperm viability results obtained using hypo osmotic swelling test, modified hypo osmotic swelling test, water test and grading of tail swelling patterns |
At the time of semen analysis |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |