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)

IVI Bilbao

Status: Withdrawn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)

Treatments: Dietary Supplement: Antioxidant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04758260

1708-BIO-088-MM

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Antioxidant Treatment

Experimental group

Description:

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

Treatment:

Dietary Supplement: Antioxidant