Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome (MI_ICSI)

AGUNCO Obstetrics and Gynecology Centre

Status: Completed

Conditions: Couple Sterility

Treatments: Other: untreated; Dietary Supplement: Myo-inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT02050672

MI_ICSI

Details and patient eligibility

About

In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes.

In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen.

Full description

Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium.

Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing hig MI concentration.

Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro fertilization rate is correlated with the percentage of high MMP spermatozoa.

Enrollment: 249 patients

Sex: Male

Ages: 30 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• couple counselled for IVF

Exclusion criteria

• cryopreserved sample

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

249 participants in 2 patient groups

untreated

Active Comparator group

Description:

Semen was prepared with routinely used media

Treatment:

Other: untreated

myo-inositol

Experimental group

Description:

routinely used semen preparation media have been enriched with myo-inositol 2mg/ml. in particular the stock solution was prepared in order to add 15microliters per ml of medium

Treatment:

Dietary Supplement: Myo-inositol