Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome

Couple Sterility Clinical Trial

— MI_ICSI  

Official title:

Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome: a Prospective, Randomized Sibling-oocyte Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050672
• Other study ID #: MI_ICSI
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: July 2021

Study information

• Verified date: July 2021
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: July 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 42 Years

Eligibility

Inclusion Criteria:

• couple counselled for IVF

Exclusion Criteria:

• cryopreserved sample

Related Conditions & MeSH terms

• Couple Sterility
• Infertility

Intervention

Dietary Supplement:
• Myo-inositol

Other:
• untreated

Locations

Country	Name	City	State
Italy	TECNOLAB	Milan

Sponsors (1)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Condorelli RA, La Vignera S, Bellanca S, Vicari E, Calogero AE. Myoinositol: does it improve sperm mitochondrial function and sperm motility? Urology. 2012 Jun;79(6):1290-5. doi: 10.1016/j.urology.2012.03.005. — View Citation

Condorelli RA, La Vignera S, Di Bari F, Unfer V, Calogero AE. Effects of myoinositol on sperm mitochondrial function in-vitro. Eur Rev Med Pharmacol Sci. 2011 Feb;15(2):129-34. — View Citation

Nomikos M, Swann K, Lai FA. Starting a new life: sperm PLC-zeta mobilizes the Ca2+ signal that induces egg activation and embryo development: an essential phospholipase C with implications for male infertility. Bioessays. 2012 Feb;34(2):126-34. doi: 10.1002/bies.201100127. Epub 2011 Nov 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetilization rate		Day 1
Secondary	Embryo quality		Day 2 to Day 5