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

Not Applicable

Withdrawn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)
• Interventions: Dietary Supplement: Antioxidant

• Registration Number: NCT04758260
• Lead Sponsor: IVI Bilbao

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-12
• Primary Completion: 2019-07-18
• Study First Submitted: 2020-03-09
• Status Verified: 2021-02
• Study Completion: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Last Update Submitted: 2021-02-12
• Study First Posted: 2021-02-17
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

• Taking oral antioxidants in the 3 months prior to inclusion in the study
• Total astenozoospermia or Severe teratozoospermia (including balloonzoospermia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IVI Bilbao; 🇪🇸 Leioa, Vizcaya, Spain