Clinical Trials Logo
  1. Home
  2. Oligospermia
  3. NCT01828710
  4. Details
NCT01828710 Clinical Trial

Myo-inositol on Human Semen Parameters

Oligospermia Clinical Trial

Official title:
Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01828710
Other study ID # INO-2103-GC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date November 2012

Study information
Verified date July 2022
Source AGUNCO Obstetrics and Gynecology Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria: Undergoing to IVF cycle OAT Exclusion Criteria: No undergoing to IVF cycle

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Myo-inositol normospermic
4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.
• Myo-inositol OAT
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 normospermic
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.

Locations
Country Name City State
Italy Centre of Physiopathology of Reproduction Catania CT

Sponsors (1)
Lead Sponsor Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary sperm concentration after 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT05506722 - Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity N/A
Recruiting NCT04795440 - Comparison of ICSI Outcomes in Cycles Using Testicular and Ejaculate Sperm From Couples With High SDF N/A
Completed NCT03898752 - Is Oxidative Stress in Semen Reduced by Lifestyle Intervention N/A
Recruiting NCT02063256 - 7 NUTS Study. Diet Modification and Male Fertility. Phase 2/Phase 3
Active, not recruiting NCT05134428 - Safety Evaluation of the ADAM System N/A
Not yet recruiting NCT06260007 - Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia Phase 4
Terminated NCT00440180 - Aromatase Inhibitors in the Treatment of Male Infertility Phase 3
Completed NCT01409837 - The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count Phase 2
Completed NCT01239186 - Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men N/A
Not yet recruiting NCT00479960 - A Preliminary Study on Effect of Omega-3 on Human Sperm Phase 0
Recruiting NCT06342856 - Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia Early Phase 1
Recruiting NCT01856361 - Ramipril for the Treatment of Oligospermia N/A
Recruiting NCT05842239 - Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia. N/A
Completed NCT01509482 - Insulin Resistance in Idiopathic Oligospermia and Azoospermia N/A
Not yet recruiting NCT01520584 - Supplement Intake in Infertile Men;the Effect on Sperm Parameters,Fertilization Rate and Embryo Quality N/A
Completed NCT00548977 - Genetic Studies Spermatogenic Failure N/A
Completed NCT04349345 - Seminal Fluid's Changes Over 20 Years
Recruiting NCT05320536 - A Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia Phase 4
Recruiting NCT05158114 - Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Testicular Injury and Oligospermia Phase 1
Completed NCT02234206 - A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count Phase 2