Myo-inositol on Human Semen Parameters
Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles
1 other identifier
interventional
62
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
April 11, 2013
CompletedJuly 25, 2022
July 1, 2022
3 months
March 21, 2013
July 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sperm concentration
after 3 months
Study Arms (3)
Myo-inositol normospermic
SHAM COMPARATOR29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
Myo-inositol OAT
ACTIVE COMPARATOR13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
Folic acid normospermic
PLACEBO COMPARATOR20 normospermic patients treated with 400 µg of folic acid
Interventions
4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.
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
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.
Eligibility Criteria
You may qualify if:
- Undergoing to IVF cycle OAT
You may not qualify if:
- No undergoing to IVF cycle
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre of Physiopathology of Reproduction
Catania, CT, 95010, Italy
Related Publications (1)
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.
PMID: 35506389DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Palumbo, M.D.
University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction
- STUDY DIRECTOR
Gianfranco Carlomagno, Ph.D.
A.G.Un.Co. Obstetrics and gynaecology center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2013
First Posted
April 11, 2013
Study Start
August 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
July 25, 2022
Record last verified: 2022-07