MyoinositolPhase 1/2NCT03153436
The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation
A Phase 1/2 study testing Myoinositol in people with Myoinositol and Cryopreservation, run by Sohag University.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Myoinositol, Cryopreservation, Human
- What is being tested?
- Myoinositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2016to 26 Apr 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile men with normal or abnormal semen analysis
Who cannot join
- Azoospermic samples
About this study
The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.
Read the 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.
- Conditions
- Myoinositol, Cryopreservation, Human, Sperm
- Being tested
- Myoinositol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoinositolBiological
| Study group | Role | What they receive |
|---|---|---|
| Normal S.A group | Active comparator | 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). Receives: Biological: Myoinositol |
| Abnormal S.A group | Active comparator | 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). Receives: Biological: Myoinositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cryo-survival rate
Post-thawing cryo-survival rates of both aliquots ( myo and control) are compared in both groups (A and B).
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start28 Aug 2016
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MyoinositolStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Ajyal Hospital
- Responsible party
- Principal investigator, Mohamed Alaa El-Dein Hasan, Sohag University
- Investigators
- Ramadan Saleh, M.D., Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153436
- Sponsor's protocol ID
- SPMYO001
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 4952185Anger 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.
PubMed 14501696Araki 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.
PubMed 26207962Bahat 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.
PubMed 19955332Beemster P, Groenen P, Steegers-Theunissen R. Involvement of inositol in reproduction. Nutr Rev. 2002 Mar;60(3):80-7. doi: 10.1301/00296640260042748.
PubMed 11908744Oberoi 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.
PubMed 25382909
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation
- ClinicalTrials.gov ID
- NCT03153436
- Acronym / sponsor ID
- SPMYO001
- Conditions
- Myoinositol, Cryopreservation, Human, Sperm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Ajyal Hospital
- Study start
- 28 Aug 2016 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal S.A group | Active comparator | Biological: MyoinositolInfertile 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 comparator | Biological: MyoinositolInfertile 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). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertile men with normal or abnormal semen analysis
Key exclusion criteria (1 listed)
- Azoospermic samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myoinositol | Biological | Abnormal S.A group, Normal S.A group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Background: PubMed 4952185Ackerman 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.
- Background: PubMed 14501696Anger 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.
- Background: PubMed 26207962Araki 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.
- Background: PubMed 19955332Bahat 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.
- Background: PubMed 11908744Beemster P, Groenen P, Steegers-Theunissen R. Involvement of inositol in reproduction. Nutr Rev. 2002 Mar;60(3):80-7. doi: 10.1301/00296640260042748.
- Background: PubMed 25382909Oberoi 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.
- Individual participant dataSharing planned: Undecided
Related trials for Myoinositol
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Recruiting
Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
PCOS (Polycystic Ovary Syndrome), Insulin Resistance
Active, not recruiting
Myo-Inositol and Folic Acid for Improving Inflammation in Polycystic Ovary Syndrome
Inflammation Biomarkers, Poly Cystic Ovary Syndrome
Recruiting
Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
Thyroid Nodule
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramadan Saleh, M.D. study director
Sohag University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Myoinositol in people with Myoinositol and Cryopreservation, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cryo-survival rate (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153436, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.