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

NCT ID: NCT03153436

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-28

Study Completion Date

2017-04-26

Brief Summary

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

Detailed Description

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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.

Conditions

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Myoinositol Cryopreservation Human Sperm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Myoinositol

Intervention Type BIOLOGICAL

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).

Group Type ACTIVE_COMPARATOR

Myoinositol

Intervention Type BIOLOGICAL

Interventions

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Myoinositol

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Infertile men with normal or abnormal semen analysis

Exclusion Criteria

* Azoospermic samples
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ajyal Hospital

OTHER

Sponsor Role collaborator

Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Alaa El-Dein Hasan

M.B.B.Ch.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramadan Saleh, M.D.

Role: STUDY_DIRECTOR

Sohag University

References

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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.

Reference Type BACKGROUND
PMID: 4952185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14501696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26207962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19955332 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11908744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25382909 (View on PubMed)

Other Identifiers

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SPMYO001

Identifier Type: -

Identifier Source: org_study_id

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