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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 26, 2017

Detailed 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.

Interventions

  • Biological: Myoinositol

Arms, Groups and Cohorts

  • Active Comparator: Normal S.A group
    • Infertile 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).
  • Active Comparator: Abnormal S.A group
    • Infertile 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).

Clinical Trial Outcome Measures

Primary Measures

  • Cryo-survival rate
    • Time Frame: 7 months
    • Post-thawing cryo-survival rates of both aliquots ( myo and control) are compared in both groups (A and B).

Participating in This Clinical Trial

Inclusion Criteria

  • Infertile men with normal or abnormal semen analysis Exclusion Criteria:

  • Azoospermic samples

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sohag University
  • Collaborator
    • Ajyal Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed Alaa El-Dein Hasan, M.B.B.Ch. – Sohag University
  • Overall Official(s)
    • Ramadan Saleh, M.D., Study Director, Sohag University

References

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.

Anger 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.

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):1004-1009. doi: 10.1016/j.fertnstert.2015.06.043. Epub 2015 Jul 21.

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.

Beemster P, Groenen P, Steegers-Theunissen R. Involvement of inositol in reproduction. Nutr Rev. 2002 Mar;60(3):80-7. doi: 10.1301/00296640260042748.

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.

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