Myo-inositol on Human Semen Parameters

Sponsor

AGUNCO Obstetrics and Gynecology Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01828710

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

20.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthenozoospermia Oligospermia	Dietary Supplement: Myo-inositol normospermic Dietary Supplement: Myo-inositol OAT Dietary Supplement: Folic Acid normospermic	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

sperm concentration [after 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Undergoing to IVF cycle OAT

Exclusion Criteria:

No undergoing to IVF cycle

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Physiopathology of Reproduction	Catania	CT	Italy	95010

Sponsors and Collaborators

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