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Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle

NCT04758260 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-17

No results posted yet for this study

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.

Conditions

  • Compare the sORP Rate in Sperm Samples, Obtained by the Mioxsys System, Before and After 2.5 Months Antioxidant Men Supplements Treatment (Fertybiotic Man)

Interventions

DIETARY_SUPPLEMENT

Antioxidant

Oral antioxidant oral intake in the 3 months prior to inclusion in the study

Sponsors & Collaborators

  • Aytu BioPharma, Inc.

    collaborator INDUSTRY

  • IVI Bilbao

    lead OTHER

Principal Investigators

  • Marcos Ferrando · IVI Bilbao

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2019-07-18
Completion
2021-02-12

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758260 on ClinicalTrials.gov