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NCT03153436 Clinical Trial

The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation

Human Clinical Trial

Official title:
The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03153436
Other study ID # SPMYO001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 11, 2017
Last updated May 13, 2017
Start date August 28, 2016
Est. completion date April 26, 2017

Study information
Verified date May 2017
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Description:

Sperm cryopreservation is considered the most valuable and used way to preserve male reproductive function. Unfortunately, osmotic effects of freezing and thawing during the cryopreservation process negatively affect sperm morphology and motility .

Myoinositol is the most biologically important form of inositol in nature. In male reproductive system, myoinositol appears to regulate sperm motility, capacitation and acrosomal reaction.

The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date April 26, 2017
Est. primary completion date April 26, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Infertile men with normal or abnormal semen analysis

Exclusion Criteria:

- Azoospermic samples

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Myoinositol

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Sohag University Ajyal Hospital

References & 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. — View Citation

Anger JT, Gilbert BR, Goldstein M. Cryopreservation of sperm: indications, methods and results. J Urol. 2003 Oct;170(4 Pt 1):1079-84. Review. — View Citation

Araki 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):1004-9. doi: 10.1016/j.fertnstert.2015.06.043. Epub 2015 Jul 21. — View Citation

Bahat 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. — View Citation

Beemster P, Groenen P, Steegers-Theunissen R. Involvement of inositol in reproduction. Nutr Rev. 2002 Mar;60(3):80-7. — View Citation

Oberoi 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cryo-survival rate Post-thawing cryo-survival rates of both aliquots ( myo and control) are compared in both groups (A and B). 7 months
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