| CTRI Number |
CTRI/2024/02/062755 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Non-randomized, Multiple Arm Trial |
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Public Title of Study
|
Simplified Method for Freezing Small Numbers of Human Spermatozoa using Sole Trehalose |
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Scientific Title of Study
|
Cryopreservation of Single Human Spermatozoa using Sole Trehalose |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Saroch Wannako |
| Designation |
Fellowship Doctor |
| Affiliation |
Prince of Songkla University |
| Address |
Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkla, Thailand
90110
Other |
| Phone |
66834088099 |
| Fax |
|
| Email |
wannakosaroch@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Kriengsak Dhanaworavibul |
| Designation |
Assistant Professor |
| Affiliation |
Prince of Songkla University |
| Address |
Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkla, Thailand
90110
Other |
| Phone |
66815406122 |
| Fax |
|
| Email |
dkrieng@yahoo.com |
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Source of Monetary or Material Support
|
| Faculty of Medicine Research Scholarship, Prince of Songkla University |
|
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Primary Sponsor
|
| Name |
Faculty of Medicine Research Scholarship, Prince of Songkla University |
| Address |
Prince of Songkla University, Hat Yai, Songkla, Thailand |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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Thailand |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saroch Wannako |
Faculty of Medicine, Prince of Songkla University |
Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University,15 Kanchanavanit, Hat Yai, Songkla, Thailand 90110
|
66834088099
-
wannakosaroch@gmail.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee, Faculty of Medicine, Prince of Songkla University |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SpermFreeze (Fertipro, Belgium) |
SpermFreeze commercial (Fertipro, Belgium) cryoprotective medium |
| Intervention |
Trehalose based cryoprotective medium |
In house Trehalose based cryoprotective medium concentration of 50 mM, 100 mM, 150 mM and 200 mM |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1.Healthy male, semen concentration of 20 million per mL or more and at least 50 percent motility
2.Correct collection method
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| ExclusionCriteria |
| Details |
1.Incorrect method : intercourse and condom used, spermicidal lubricant used
2.Abnormal semen analysis
3.Semen delivered to the laboratory for more than 1 hour
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Post thaw recovery rate, post thaw motility rate |
24 hours |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Post thaw progressive motility rate |
24 hours |
|
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Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
26/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="1"
Days="1" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dkrieng@yahoo.com].
- For how long will this data be available start date provided 15-01-2024 and end date provided 15-01-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
This study is nonrandomized, single blind, parallel group, single center trial comparing post thaw recovery rate, motility rate and progressive motility rate of different concentration trehalose based cryoprotectant to SpermFreeze comercial (Fertipro, Belgium) in 10 health male with 250 spermatozoa per person, total 2500 spermatozoa that will be conducted in one center in Thailand |