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NCT04758260 | Withdrawn DMC

• 1 other identifier: 1708-BIO-088-MM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate the influence of the sORP rate in embryo development

  1 year

• Evaluate the relationship between the sORP rate in sperm samples

  1 year

• Determinate a reproductive prognosis value based on sORP rate and the different sperm parameters

  1 year

Study Arms (1)

Antioxidant Treatment

EXPERIMENTAL

Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men

Dietary Supplement: Antioxidant

Interventions

Antioxidant DIETARY_SUPPLEMENT

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

Antioxidant Treatment

Eligibility Criteria

• Age: 18 Years - 48 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sperm count greater than 2 million per milliliter
• Sperm origin: ejaculate

You may not qualify if:

• Total astenozoospermia or Severe teratozoospermia (including balloonzoospermia)

Sponsors & Collaborators

• IVI Bilbao: lead
• Aytu BioPharma, Inc.: collaborator

Study Sites (1)

IVI Bilbao

Leioa, Vizcaya, 48940, Spain

Location

MeSH Terms

Interventions

Antioxidants

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Marcos Ferrando

  IVI Bilbao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marcos Ferrando Serrano

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: February 17, 2021
• Study Start: February 12, 2019
• Primary Completion: July 18, 2019
• Study Completion: February 12, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)