Myo-inositol on Human Semen Parameters

Not Applicable

Completed

• Conditions: Oligospermia; Asthenozoospermia
• Interventions: Dietary Supplement: Myo-inositol OAT; Dietary Supplement: Myo-inositol normospermic; Dietary Supplement: Folic Acid normospermic

• Registration Number: NCT01828710
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

Inclusion Criteria

Undergoing to IVF cycle OAT

Exclusion Criteria

No undergoing to IVF cycle

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myo-inositol OAT	Myo-inositol OAT	13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
Myo-inositol normospermic	Myo-inositol normospermic	29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
Folic acid normospermic	Folic Acid normospermic	20 normospermic patients treated with 400 µg of folic acid

Primary Outcome Measures

Name	Time	Method
sperm concentration	after 3 months

Trial Locations

Locations (1)

Centre of Physiopathology of Reproduction; 🇮🇹 Catania, CT, Italy