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

May 13, 2017 updated by: Mohamed Alaa El-Dein Hasan, Sohag University
The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Infertile men with normal or abnormal semen analysis

Exclusion Criteria:

  • Azoospermic samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Biological: Myoinositol
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).
Biological: Myoinositol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Collaborators

Ajyal Hospital

Investigators

  • Study Director: Ramadan Saleh, M.D., Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2016

Primary Completion (ACTUAL)

April 26, 2017

Study Completion (ACTUAL)

April 26, 2017

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (ACTUAL)

May 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 13, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPMYO001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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