Couple Sterility Clinical Trial
— MI_ICSIOfficial title:
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome: a Prospective, Randomized Sibling-oocyte Study
NCT number | NCT02050672 |
Other study ID # | MI_ICSI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | July 2021 |
Verified date | July 2021 |
Source | AGUNCO Obstetrics and Gynecology Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | TECNOLAB | Milan |
Lead Sponsor | Collaborator |
---|---|
AGUNCO Obstetrics and Gynecology Centre |
Italy,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fetilization rate | Day 1 | ||
Secondary | Embryo quality | Day 2 to Day 5 |