Sperm QualityPhase 4NCT01560065
Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing In Vitro Fertilization Cycles
A Phase 4 study testing myo-inositol + folic acid in people with Sperm Quality and Oligoasthenospermia, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules is higher than in serum and it was increasing during the movement through the epididymis and the deferent duct. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Sperm Quality, Oligoasthenospermia
- What is being tested?
- myo-inositol + folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 18 to 40 years
- Men only
- Adult
Who may be able to join
- 3-5 days of sexual abstinence
Who cannot join
- systemic and endocrine diseases
- genital infections
- history of cryptorchidism or varicocele
- microorchidism
- hormonal treatment in the last six months
- alcohol intake, cigarette smoke and/or drug abuse
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Catania - Department of Surgery - Section of Obstetrics and Gynecology -Center of Physiopathology of Reproduction
Catania
About this study
Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules is higher than in serum and it was increasing during the movement through the epididymis and the deferent duct. In the present study, the role of myo-inositol has been investigated as a possible antioxidant agent for the systemic treatment of male infertility and the improvement of the sperm's quality.
Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF cycle: healthy subjects and subjects with oligoasthenospermia (OA, < 15 mil/ml). The collected samples were submitted to optic microscopy in order to evaluate semen's volume, spermatozoa's number and motility, during the initial semen analysis and after density gradient separation method; these parameters were evaluated before and after the administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid for three months.
These values were compared with samples of seminal fluid of healthy patients undergoing to a IVF cycle for a female cause of infertility (control group).
- Conditions
- Sperm Quality, Oligoasthenospermia
- Being tested
- myo-inositol + folic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myo-inositol + folic acidDietary supplement
4000mg myo-inositol + 400 µg folic acid
myo-inositol + folic acidDietary supplement
4000mg myo-inositol + 400 µg folic acid
| Study group | Role | What they receive |
|---|---|---|
| Normospermic patients | Other | Not described Receives: Dietary Supplement: myo-inositol + folic acid |
| Oligoasthenospermic patients | Other | Not described Receives: Dietary Supplement: myo-inositol + folic acid |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen volume
Spermatozoa count
Spermatozoa progressive motility
Number of spermatozoa after density gradient separation method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
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 Sperm QualityStudies 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 4
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
- NCT01560065
- Sponsor's protocol ID
- MI_IVF
- Status last verified
- Jan 2012
- First submitted
- 20 Mar 2012
- Last updated
- 22 Mar 2012
- Results posted
- No
Publications
Colone M, Marelli G, Unfer V, Bozzuto G, Molinari A, Stringaro A. Inositol activity in oligoasthenoteratospermia--an in vitro study. Eur Rev Med Pharmacol Sci. 2010 Oct;14(10):891-6.
PubMed 21222378Hinton BT, White RW, Setchell BP. Concentrations of myo-inositol in the luminal fluid of the mammalian testis and epididymis. J Reprod Fertil. 1980 Mar;58(2):395-9. doi: 10.1530/jrf.0.0580395.
PubMed 7431272de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
PubMed 35506389
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing In Vitro Fertilization Cycles
- ClinicalTrials.gov ID
- NCT01560065
- Acronym / sponsor ID
- MI_IVF
- Conditions
- Sperm Quality, Oligoasthenospermia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- First posted
- 22 Mar 2012 (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.
Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules is higher than in serum and it was increasing during the movement through the epididymis and the deferent duct. In the present study, the role of myo-inositol has been investigated as a possible antioxidant agent for the systemic treatment of male infertility and the improvement of the sperm's quality.
Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF cycle: healthy subjects and subjects with oligoasthenospermia (OA, < 15 mil/ml). The collected samples were submitted to optic microscopy in order to evaluate semen's volume, spermatozoa's number and motility, during the initial semen analysis and after density gradient separation method; these parameters were evaluated before and after the administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid for three months.
These values were compared with samples of seminal fluid of healthy patients undergoing to a IVF cycle for a female cause of infertility (control group).
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normospermic patients | Other | Dietary Supplement: myo-inositol + folic acid |
| Oligoasthenospermic patients | Other | Dietary Supplement: myo-inositol + folic acid |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 3-5 days of sexual abstinence
Key exclusion criteria (6 listed)
- systemic and endocrine diseases
- genital infections
- history of cryptorchidism or varicocele
- microorchidism
- hormonal treatment in the last six months
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 + folic acid4000mg myo-inositol + 400 µg folic acid | Dietary supplement | Normospermic patients |
| myo-inositol + folic acid4000mg myo-inositol + 400 µg folic acid | Dietary supplement | Oligoasthenospermic patients |
Primary outcome
Semen volume
Spermatozoa count
Spermatozoa progressive motility
Number of spermatozoa after density gradient separation method
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 22 Mar 2012.
- Background: PubMed 21222378Colone M, Marelli G, Unfer V, Bozzuto G, Molinari A, Stringaro A. Inositol activity in oligoasthenoteratospermia--an in vitro study. Eur Rev Med Pharmacol Sci. 2010 Oct;14(10):891-6.
- Background: PubMed 7431272Hinton BT, White RW, Setchell BP. Concentrations of myo-inositol in the luminal fluid of the mammalian testis and epididymis. J Reprod Fertil. 1980 Mar;58(2):395-9. doi: 10.1530/jrf.0.0580395.
- Derived from this study: PubMed 35506389de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
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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 Phase 4 study testing myo-inositol + folic acid in people with Sperm Quality and Oligoasthenospermia, 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 6 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 22 Mar 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Semen volume. The study lists 4 primary outcomes in all. 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 NCT01560065, 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 22 Mar 2012.