Myo-inositol on Human Semen Parameters

AGUNCO Obstetrics and Gynecology Centre

Status: Completed

Conditions: Oligospermia; Asthenozoospermia

Treatments: Dietary Supplement: Myo-inositol OAT; Dietary Supplement: Folic Acid normospermic; Dietary Supplement: Myo-inositol normospermic

Study type: Interventional

Funder types: Other

Identifiers

NCT01828710

INO-2103-GC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Undergoing to IVF cycle OAT

Exclusion criteria

No undergoing to IVF cycle

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups, including a placebo group

Myo-inositol normospermic

Sham Comparator group

Description:

29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid

Treatment:

Dietary Supplement: Myo-inositol normospermic

Myo-inositol OAT

Active Comparator group

Description:

13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid

Treatment:

Dietary Supplement: Myo-inositol OAT

Folic acid normospermic

Placebo Comparator group

Description:

20 normospermic patients treated with 400 µg of folic acid

Treatment:

Dietary Supplement: Folic Acid normospermic