AsthenozoospermiaNCT01828710
Myo-inositol on Human Semen Parameters
A study testing Myo-inositol normospermic, Myo-inositol OAT and Folic Acid normospermic in people with Asthenozoospermia and Oligospermia, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
Many clinical evidences suggest that Myo-inositol plays a crucial role in human reproduction. Also, it was shown that Myo-inositol concentration in the seminiferous tubules was higher than in serum, and interestingly it was increasing through the epididymis and the deferent duct mining that sperm cell before… Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthenozoospermia, Oligospermia
- What is being tested?
- Myo-inositol normospermic, Myo-inositol OAT and Folic Acid normospermic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2012to Nov 2012
- 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 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing to IVF cycle OAT
Who cannot join
- No undergoing to IVF cycle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles
Many clinical evidences suggest that Myo-inositol plays a crucial role in human reproduction. Also, it was shown that Myo-inositol concentration in the seminiferous tubules was higher than in serum, and interestingly it was increasing through the epididymis and the deferent duct mining that sperm cell before ejaculation are stored in a "medium" highly enriched in myo-inositol.
Starting from this evidences, the investigators hypothesized that myo-inositol may be a possible factor able to improve the semen parameters of samples used in in vitro fertilization cycles.
Read the detailed description
Samples of seminal fluid were obtained from two groups of patients undergoing to an IVF cycle: healthy normospermic subjects and subjects with oligoasthenoteratospermia (OAT, < 15 mil/ml).
Semen volume, spermatozoa number and motility were evaluated 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 (Inofolic lolipharma Rome) for three months.
A third group of healthy normospermic subject were traded with 400 µg of folic acid for three months and was consider a control group.
- Conditions
- Asthenozoospermia, Oligospermia
- Being tested
- Myo-inositol normospermic, Myo-inositol OAT, Folic Acid normospermic
- Keywords
- Myo-inositol, oligoasthenoteratospermia, semen parameters, IVF
- Medical subject headings
- Asthenozoospermia, Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositol normospermicDietary supplement
4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.
Myo-inositol OATDietary supplement
B 13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months
Folic Acid normospermicDietary supplement
Group C 20 normospermic patients treated with 400 µg of folic acid (kindly provided by Lo.Li. pharma s.r.l., Roma) for three months.
| Study group | Role | What they receive |
|---|---|---|
| Myo-inositol normospermic | Sham comparator | 29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid Receives: Dietary Supplement: Myo-inositol normospermic |
| Myo-inositol OAT | Active comparator | 13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid Receives: Dietary Supplement: Myo-inositol OAT |
| Folic acid normospermic | Placebo comparator | 20 normospermic patients treated with 400 µg of folic acid Receives: Dietary Supplement: Folic Acid normospermic |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm concentration
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthenozoospermiaStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Palumbo, M.D., Principal investigator, University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of ReproductionGianfranco Carlomagno, Ph.D., Study director, A.G.Un.Co. Obstetrics and gynaecology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828710
- Sponsor's protocol ID
- INO-2103-GC
- Status last verified
- Jul 2022
- First submitted
- 21 Mar 2013
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de 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 25 Jul 2022. 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 IVF Cycles
- ClinicalTrials.gov ID
- NCT01828710
- Acronym / sponsor ID
- INO-2103-GC
- Conditions
- Asthenozoospermia, Oligospermia
- Keywords
- Myo-inositol, oligoasthenoteratospermia, semen parameters, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Apr 2013 (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.
Many clinical evidences suggest that Myo-inositol plays a crucial role in human reproduction. Also, it was shown that Myo-inositol concentration in the seminiferous tubules was higher than in serum, and interestingly it was increasing through the epididymis and the deferent duct mining that sperm cell before ejaculation are stored in a "medium" highly enriched in myo-inositol.
Starting from this evidences, the investigators hypothesized that myo-inositol may be a possible factor able to improve the semen parameters of samples used in in vitro fertilization cycles.
Detailed description
Samples of seminal fluid were obtained from two groups of patients undergoing to an IVF cycle: healthy normospermic subjects and subjects with oligoasthenoteratospermia (OAT, < 15 mil/ml).
Semen volume, spermatozoa number and motility were evaluated 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 (Inofolic lolipharma Rome) for three months.
A third group of healthy normospermic subject were traded with 400 µg of folic acid for three months and was consider a control group.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myo-inositol normospermic | Sham comparator | Dietary Supplement: Myo-inositol normospermic29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid |
| Myo-inositol OAT | Active comparator | Dietary Supplement: Myo-inositol OAT13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid |
| Folic acid normospermic | Placebo comparator | Dietary Supplement: Folic Acid normospermic20 normospermic patients treated with 400 µg of folic acid |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing to IVF cycle OAT
Key exclusion criteria (1 listed)
- No undergoing to IVF cycle
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 normospermic4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months. | Dietary supplement | Myo-inositol normospermic |
| Myo-inositol OATB 13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months | Dietary supplement | Myo-inositol OAT |
| Folic Acid normospermicGroup C 20 normospermic patients treated with 400 µg of folic acid (kindly provided by Lo.Li. pharma s.r.l., Roma) for three months. | Dietary supplement | Folic acid normospermic |
Primary outcome
sperm concentration
Time frame: after 3 months
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 25 Jul 2022.
- 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.
Related trials for Asthenozoospermia
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
Recruiting
Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress
Male Infertility, Oxidative Stress
Recruiting
Probiotics on Sperm Quality in Male Infertility Patients
Male Infertility, Oligozoospermia
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.
Marco Palumbo, M.D. principal investigator
University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction
Gianfranco Carlomagno, Ph.D. study director
A.G.Un.Co. Obstetrics and gynaecology center
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 normospermic, Myo-inositol OAT and Folic Acid normospermic in people with Asthenozoospermia and Oligospermia, 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 25 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
sperm concentration (time frame: after 3 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 NCT01828710, which also lists 1 linked publication.
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 25 Jul 2022.