Myo-inositol on Human Semen Parameters

July 20, 2022 updated by: AGUNCO Obstetrics and Gynecology Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CT
      • Catania, CT, Italy, 95010
        • Centre of Physiopathology of Reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Undergoing to IVF cycle OAT

Exclusion Criteria:

No undergoing to IVF cycle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Myo-inositol normospermic
29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
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.
Active Comparator: Myo-inositol OAT
13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
Dietary supplement: 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
Placebo Comparator: Folic acid normospermic
20 normospermic patients treated with 400 µg of folic acid
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sperm concentration
Time Frame: after 3 months
after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INO-2103-GC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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