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

NCT ID: NCT04758260

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-12

Study Completion Date

2021-02-12

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antioxidant Treatment

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

Group Type EXPERIMENTAL

Antioxidant

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Antioxidant

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Aytu BioPharma, Inc.

INDUSTRY

Sponsor Role collaborator

IVI Bilbao

OTHER

Sponsor Role lead

Responsible Party

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FERNANDO QUINTANA FERRAZ

Marcos Ferrando Serrano

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcos Ferrando

Role: PRINCIPAL_INVESTIGATOR

IVI Bilbao

Locations

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IVI Bilbao

Leioa, Vizcaya, Spain

Site Status

Countries

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Spain

Other Identifiers

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1708-BIO-088-MM

Identifier Type: -

Identifier Source: org_study_id

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