Compare the sORP Rate in Sperm Samples, Obtained by the Mioxsys System, Before and After 2.5 Months Antioxidant Men Supplements Treatment (Fertybiotic Man) Clinical Trial
— Mioxsys oxOfficial title:
Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle
| Verified date | February 2021 |
| Source | IVI Bilbao |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Evaluate the influence of antioxidant men supplements treatment (Fertybiotic Hombre) in the rate of sORP (stactic Oxidation Reduction Potential) defined as the balanced measure between the total oxidant activity (ROS, superoxides, nitric oxide, peroxide) and total reducing activity (alpha tocopherol, β carotene, uric acid) in sperm samples during egg donation cycles. We will also evaluate the influence of the sORP rate in the embryo development during the egg donation treatments; taking in account the fecundation rate, percentage of blastocyst stage arrival embryos, number of frozen embryos, implantation rate, on-going pregnancy rate and miscarriage rate. The sperm sample will be measured by electrochemical technology using Mioxsys system for a quantitative measurement in millivolts (mV), in those male patients who participate in an egg donation assisted reproduction treatment. After 14 days, the pregnancy stage will be available. This information will be obtained from the patient's clinical history using the human chorionic gonadotropin hormone (shCG) in blood. It will be performed either in our Clinic or externally within the usual practice derived from the treatment carried out. These values will be compared with the results obtained from sORP.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | February 12, 2021 |
| Est. primary completion date | July 18, 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 48 Years |
| Eligibility | Male Inclusion Criteria - Sperm count greater than 2 million per milliliter - Sperm origin: ejaculate Exclusion Criteria: - Taking oral antioxidants in the 3 months prior to inclusion in the study - Total astenozoospermia or Severe teratozoospermia (including balloonzoospermia) |
| Country | Name | City | State |
|---|---|---|---|
| Spain | IVI Bilbao | Leioa | Vizcaya |
| Lead Sponsor | Collaborator |
|---|---|
| IVI Bilbao | Aytu BioScience, Inc. |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Compare the sORP rate in sperm samples, | Compare the sORP rate in sperm samples, obtained by the Mioxsys System, before and after 2.5 months antioxidant men supplements treatment (Fertybiotic MAN). | 2.5 months | |
| Secondary | Evaluate the influence of the sORP rate in embryo development | Analysis of different embryo quality parameters as:
fecundation rate percentage of blastocyst stage arrival embryos number of frozen embryos |
1 year | |
| Secondary | Evaluate the relationship between the sORP rate in sperm samples | Evaluate the relationship between the sORP rate in sperm samples, obtained by Mioxsys System, with the implantation rate, on-going pregnancy rate and miscarriage rate. | 1 year | |
| Secondary | Determinate a reproductive prognosis value based on sORP rate and the different sperm parameters | 1 year |