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

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.

Study Overview

• Status: Withdrawn
• 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)
• Intervention / Treatment: Dietary supplement: Antioxidant

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Vizcaya
    • Leioa, Vizcaya, Spain, 48940
      • IVI Bilbao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Antioxidant Treatment; Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men	Dietary supplement: Antioxidant; Oral antioxidant oral intake in the 3 months prior to inclusion in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Determinate a reproductive prognosis value based on sORP rate and the different sperm parameters		1 year

Collaborators and Investigators

• Sponsor: IVI Bilbao
• Collaborators: Aytu BioPharma, Inc.
• Investigators: Principal Investigator: Marcos Ferrando, IVI Bilbao

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2019
• Primary Completion (ACTUAL): July 18, 2019
• Study Completion (ACTUAL): February 12, 2021

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (ACTUAL): February 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: 1708-BIO-088-MM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No