Couple SterilityMI_ICSINCT02050672
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome
A study testing Myo-inositol and untreated in people with Couple Sterility, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes. In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen. Read more about this study
- Who is it for?
- Ages 30 to 42 years, men only
- Conditions the study is for
- Couple Sterility
- What is being tested?
- Myo-inositol and untreated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Jul 2021
- Phase
- Interventional
- 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 30 to 42 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- couple counselled for IVF
Who cannot join
- cryopreserved sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome: a Prospective, Randomized Sibling-oocyte Study
In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes.
In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen.
Read the detailed description
Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium.
Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing hig MI concentration.
Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro fertilization rate is correlated with the percentage of high MMP spermatozoa.
- Conditions
- Couple Sterility
- Being tested
- Myo-inositol, untreated
- Keywords
- Myoinositol, ART, EMBRYO QUALITY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDietary supplement
untreatedOther
| Study group | Role | What they receive |
|---|---|---|
| untreated | Active comparator | Semen was prepared with routinely used media Receives: Other: untreated |
| myo-inositol | Experimental | routinely used semen preparation media have been enriched with myo-inositol 2mg/ml.
in particular the stock solution was prepared in order to add 15microliters per ml of medium Receives: Dietary Supplement: Myo-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetilization rate
Measured: Day 1
Secondary outcomes (1)
Embryo quality
Measured: Day 2 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Couple SterilityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050672
- Sponsor's protocol ID
- MI_ICSI
- Acronym
- MI_ICSI
- Status last verified
- Jul 2021
- First submitted
- 27 Jan 2014
- Last updated
- 6 Aug 2021
- Results posted
- No
Publications
Condorelli RA, La Vignera S, Bellanca S, Vicari E, Calogero AE. Myoinositol: does it improve sperm mitochondrial function and sperm motility? Urology. 2012 Jun;79(6):1290-5. doi: 10.1016/j.urology.2012.03.005.
PubMed 22656408Nomikos M, Swann K, Lai FA. Starting a new life: sperm PLC-zeta mobilizes the Ca2+ signal that induces egg activation and embryo development: an essential phospholipase C with implications for male infertility. Bioessays. 2012 Feb;34(2):126-34. doi: 10.1002/bies.201100127. Epub 2011 Nov 16.
PubMed 22086556Condorelli RA, La Vignera S, Di Bari F, Unfer V, Calogero AE. Effects of myoinositol on sperm mitochondrial function in-vitro. Eur Rev Med Pharmacol Sci. 2011 Feb;15(2):129-34.
PubMed 21434479
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome: a Prospective, Randomized Sibling-oocyte Study
- ClinicalTrials.gov ID
- NCT02050672
- Acronym / sponsor ID
- MI_ICSI / MI_ICSI
- Conditions
- Couple Sterility
- Keywords
- Myoinositol, ART, EMBRYO QUALITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes.
In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen.
Detailed description
Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium.
Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing hig MI concentration.
Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro fertilization rate is correlated with the percentage of high MMP spermatozoa.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| untreated | Active comparator | Other: untreatedSemen was prepared with routinely used media |
| myo-inositol | Experimental | Dietary Supplement: Myo-inositolroutinely used semen preparation media have been enriched with myo-inositol 2mg/ml. in particular the stock solution was prepared in order to add 15microliters per ml of medium |
Who may qualify
- Ages
- 30 to 42 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- couple counselled for IVF
Key exclusion criteria (1 listed)
- cryopreserved sample
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 |
|---|---|---|
| Myo-inositol | Dietary supplement | myo-inositol |
| untreated | Other | untreated |
Primary outcome
Fetilization rate
Time frame: Day 1
1 secondary outcome
Embryo quality
Time frame: Day 2 to Day 5
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 6 Aug 2021.
- Background: PubMed 22656408Condorelli RA, La Vignera S, Bellanca S, Vicari E, Calogero AE. Myoinositol: does it improve sperm mitochondrial function and sperm motility? Urology. 2012 Jun;79(6):1290-5. doi: 10.1016/j.urology.2012.03.005.
- Background: PubMed 22086556Nomikos M, Swann K, Lai FA. Starting a new life: sperm PLC-zeta mobilizes the Ca2+ signal that induces egg activation and embryo development: an essential phospholipase C with implications for male infertility. Bioessays. 2012 Feb;34(2):126-34. doi: 10.1002/bies.201100127. Epub 2011 Nov 16.
- Background: PubMed 21434479Condorelli RA, La Vignera S, Di Bari F, Unfer V, Calogero AE. Effects of myoinositol on sperm mitochondrial function in-vitro. Eur Rev Med Pharmacol Sci. 2011 Feb;15(2):129-34.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myo-inositol and untreated in people with Couple Sterility, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
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 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Fetilization rate (time frame: Day 1). 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 NCT02050672, which also lists 3 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 6 Aug 2021.