The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation
1 other identifier
interventional
41
0 countries
N/A
Brief Summary
The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2016
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2017
CompletedFirst Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 15, 2017
CompletedMay 16, 2017
May 1, 2017
8 months
May 11, 2017
May 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cryo-survival rate
Post-thawing cryo-survival rates of both aliquots ( myo and control) are compared in both groups (A and B).
7 months
Study Arms (2)
Normal S.A group
ACTIVE COMPARATORInfertile men with normal semen analysis. each sample is divided into 2 identical aliquots: one aliquot (Myo aliquot) is supplied with myoinositol, The other aliquot is left as it is (control aliquot).
Abnormal S.A group
ACTIVE COMPARATORInfertile men with abnormal semen analysis. each sample is divided into 2 identical aliquots: one aliquot (Myo aliquot) is supplied with myoinositol, The other aliquot is left as it is (control aliquot).
Interventions
Eligibility Criteria
You may qualify if:
- Infertile men with normal or abnormal semen analysis
You may not qualify if:
- Azoospermic samples
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
- Ajyal Hospitalcollaborator
Related Publications (6)
Ackerman DR. The effect of cooling and freezing on the aerobic and anaerobic lactic acid production of human semen. Fertil Steril. 1968 Jan-Feb;19(1):123-8. doi: 10.1016/s0015-0282(16)36552-9. No abstract available.
PMID: 4952185BACKGROUNDAnger JT, Gilbert BR, Goldstein M. Cryopreservation of sperm: indications, methods and results. J Urol. 2003 Oct;170(4 Pt 1):1079-84. doi: 10.1097/01.ju.0000084820.98430.b8.
PMID: 14501696BACKGROUNDAraki Y, Yao T, Asayama Y, Matsuhisa A, Araki Y. Single human sperm cryopreservation method using hollow-core agarose capsules. Fertil Steril. 2015 Oct;104(4):1004-1009. doi: 10.1016/j.fertnstert.2015.06.043. Epub 2015 Jul 21.
PMID: 26207962BACKGROUNDBahat A, Eisenbach M. Human sperm thermotaxis is mediated by phospholipase C and inositol trisphosphate receptor Ca2+ channel. Biol Reprod. 2010 Mar;82(3):606-16. doi: 10.1095/biolreprod.109.080127. Epub 2009 Dec 2.
PMID: 19955332BACKGROUNDBeemster P, Groenen P, Steegers-Theunissen R. Involvement of inositol in reproduction. Nutr Rev. 2002 Mar;60(3):80-7. doi: 10.1301/00296640260042748.
PMID: 11908744BACKGROUNDOberoi B, Kumar S, Talwar P. Study of human sperm motility post cryopreservation. Med J Armed Forces India. 2014 Oct;70(4):349-53. doi: 10.1016/j.mjafi.2014.09.006. Epub 2014 Oct 16.
PMID: 25382909BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ramadan Saleh, M.D.
Sohag University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.B.B.Ch.
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 15, 2017
Study Start
August 28, 2016
Primary Completion
April 26, 2017
Study Completion
April 26, 2017
Last Updated
May 16, 2017
Record last verified: 2017-05