Myo-inositol on Human Semen Parameters
Primary Purpose
Asthenozoospermia, Oligospermia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Myo-inositol normospermic
Myo-inositol OAT
Folic Acid normospermic
Sponsored by
About this trial
This is an interventional screening trial for Asthenozoospermia focused on measuring Myo-inositol, oligoasthenoteratospermia, semen parameters, IVF
Eligibility Criteria
Inclusion Criteria:
Undergoing to IVF cycle OAT
Exclusion Criteria:
No undergoing to IVF cycle
Sites / Locations
- Centre of Physiopathology of Reproduction
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Placebo Comparator
Arm Label
Myo-inositol normospermic
Myo-inositol OAT
Folic acid normospermic
Arm Description
29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
20 normospermic patients treated with 400 µg of folic acid
Outcomes
Primary Outcome Measures
sperm concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT01828710
First Posted
March 21, 2013
Last Updated
July 20, 2022
Sponsor
AGUNCO Obstetrics and Gynecology Centre
1. Study Identification
Unique Protocol Identification Number
NCT01828710
Brief Title
Myo-inositol on Human Semen Parameters
Official Title
Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGUNCO Obstetrics and Gynecology Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthenozoospermia, Oligospermia
Keywords
Myo-inositol, oligoasthenoteratospermia, semen parameters, IVF
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Myo-inositol normospermic
Arm Type
Sham Comparator
Arm Description
29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
Arm Title
Myo-inositol OAT
Arm Type
Active Comparator
Arm Description
13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
Arm Title
Folic acid normospermic
Arm Type
Placebo Comparator
Arm Description
20 normospermic patients treated with 400 µg of folic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol normospermic
Intervention Description
4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol OAT
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic Acid normospermic
Intervention Description
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.
Primary Outcome Measure Information:
Title
sperm concentration
Time Frame
after 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergoing to IVF cycle OAT
Exclusion Criteria:
No undergoing to IVF cycle
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Palumbo, M.D.
Organizational Affiliation
University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gianfranco Carlomagno, Ph.D.
Organizational Affiliation
A.G.Un.Co. Obstetrics and gynaecology center
Official's Role
Study Director
Facility Information:
Facility Name
Centre of Physiopathology of Reproduction
City
Catania
State/Province
CT
ZIP/Postal Code
95010
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
35506389
Citation
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.
Results Reference
derived
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Myo-inositol on Human Semen Parameters
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