Compare the sORP Rate in Sperm Samples, Obtained by the Mioxsys System, Before and After 2.5 Months Antioxidant Men Supplements Treatment (Fertybiotic Man)
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAntioxidant
Oral antioxidant oral intake in the 3 months prior to inclusion in the study
Sponsors
Aytu BioPharma, Inc.
IVI Bilbao
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the sORP rate in sperm samples, | 2.5 months | Compare the sORP rate in sperm samples, obtained by the Mioxsys System, before and after 2.5 months antioxidant men supplements treatment (Fertybiotic MAN). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the influence of the sORP rate in embryo development | 1 year | Analysis of different embryo quality parameters as: * fecundation rate * percentage of blastocyst stage arrival embryos * number of frozen embryos |
| Evaluate the relationship between the sORP rate in sperm samples | 1 year | 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. |
| Determinate a reproductive prognosis value based on sORP rate and the different sperm parameters | 1 year | — |
Countries
Spain
Outcome results
None listed