Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome

Not Applicable

Completed

• Conditions: Couple Sterility
• Interventions: Other: untreated; Dietary Supplement: Myo-inositol

• Registration Number: NCT02050672
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Primary Completion: 2021-01
• Status Verified: 2021-07
• Study Completion: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 249

Inclusion Criteria

• couple counselled for IVF

Exclusion Criteria

• cryopreserved sample

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
untreated	untreated	Semen was prepared with routinely used media
myo-inositol	Myo-inositol	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

Primary Outcome Measures

Name	Time	Method
Fetilization rate	Day 1

Secondary Outcome Measures

Name	Time	Method
Embryo quality	Day 2 to Day 5

Trial Locations

Locations (1)

TECNOLAB; 🇮🇹 Milan, Italy