Impact of Antioxidant Treatment on DNA Fragmentation Index (Androferti)

March 14, 2018 updated by: Aleksander Giwercman, Region Skane

Impact of Antioxidant (Androferti) Treatment on Sperm DNA Integrity

Increased sperm DNA Fragmentation Index implies decreased male fertility in vivo and in vitro. There is need for developing new strategies for improvement of male fertility. The study aims to investigate whether high sperm DNA Integration Index can be treated by use of antioxidants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the Western world, approximately 15-20% of couples experience infertility problems during their reproductive life. In this context ´'infertility' is defined as 12 months of unprotected intercourse without getting pregnant.

Although there is limited access to reliable diagnostic methods, it is assumed that in at least 50% of all cases 'male subfertility' is a contributing or the main cause of the infertility of the couple. The gold standard in assessment of male reproductive function is standard semen analysis including evaluation of sperm number, motility and morphology. Although efforts have been made in to improve and standardise the methodology for semen analysis, there are no well established cut off levels for sperm concentration, motility or morphology which accurately predict the chance of pregnancy or indicate which assisted reproductive technique (ART) - the most frequent therapy for infertility- will ultimately be the most effective. This lack of diagnostic tools is not only hampering proper management of infertility but also represents a serious limitation in relation to the understanding of biological underpinnings of the disorder and as a consequence, the development of cause related treatment modalities.

Although various novel alternative methods of assessing semen quality have been developed, so far, none have contributed to or altered our clinical approach to the treatment of infertile couples. During the passed two decades a lot of attention has been paid to impairment of sperm DNA integrity as a possible cause of male subfertility. There are different techniques currently available for the assessment of sperm DNA integrity e.g. Sperm Chromatin Structure Assay (SCSA®), Comet, TUNEL and sperm chromatin dispersion test. Generally, the use of these tests has shown an increased proportion of sperm with fragmented DNA structure among subfertile men as compared to proven fertile or men from general population. Although measuring different characteristics of the status of sperm DNA (e.g. presence of single and double strand breaks, propensity to damage and probable cause of the fragmentation), comparisons of the results obtained with two or more of these tests show a correlation coefficient of a magnitude 0.4 to 0.6, indicating that, although not completely overlapping, the tests to a certain extent assess some of the same characteristics of sperm DNA. Another interesting finding is that there is only a weak to moderate correlation between standard sperm parameters and measures of DNA integrity, the level of association (correlation coefficient ~ 0.6) the most pronounced being for motility. This means that assessment of sperm chromatin integrity adds to the information obtained by standard semen analysis.

The most appraised, standardised and studied of the sperm nDNA tests is the SCSA® which is based on a very well defined protocol for handling of samples and subsequent data analysis. The robustness of the techniques was exemplified by a comparison of the SCSA® analysis of almost 200 samples results performed by two independent laboratories which found a correlation coefficient of 0.9 with mean difference between the DNA Fragmentation Index (DFI) results of about 1%. A further advantage of the SCSA® method over the remaining assessment techniques is the relatively large number of studies that have utilised the technique in clinical settings constituting a considerable record of the method's performance in predicting fertility outcome.

Briefly, these data indicate that the chance of spontaneous pregnancy decreases at DFI levels above 20% and approaches zero if DFI exceeds 30%. This is also true for Intrauterine insemination (IUI). However, it seems that even spermatozoa from samples with high DFI can be used for in vitro fertilisation by standard IVF or ICSI, with some data suggesting that ICSI might actually be more efficient using samples with high (>30%) DFI. A finding, which may at first appear paradoxical but may be a reflection of the relative probability of fortuitously selecting a sperm with intact DNA. The data regarding fertilisation rate, embryo quality and risk of miscarriage in relation to DFI are also conflicting.

The biological mechanisms responsible for DNA strand breaks and other types of impairment of sperm DNA integrity are not completely known. Amongst others incomplete DNA repair during spermiogenesis, abortive apoptosis and/or increased level of oxidative stress have been suggested as possible options .

The overall aim of this project is to evaluate effect of restoring oxidant balance using Androferti, (Q Pharma Laboratories; Alicante, Spain) on sperm DNA integrity in subfertile men with high level of DFI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Referred due to infertility
  2. Age: 18-50 years,
  3. Non-smoking,
  4. Sperm DNA Fragmentation Index >25%

Exclusion Criteria:

  1. Body mass index (BMI) ≥30,
  2. FSH outside the normal range of 2-8 IU/L,g)
  3. LH outside the normal range of 2-10 IU/L,
  4. T < 10nmol/L
  5. Treated with antihypertensive drugs, hormones, statins, psychotropic drugs, or oral cortisone for the last six months,
  6. History of anabolic steroids use,
  7. Taking antioxidant supplementation the last six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Antioxidant
Androferti - 1 twice per day
Dietary supplement: Androferti
Placebo Comparator: Placebo
Placebo - 1 twice per day
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DFI_3
Time Frame: Change in DNA Fragmentation Index from Baseline to 3 months
3_month_change_DNA Fragmentation Index assessed by Sperm Chromatin
Change in DNA Fragmentation Index from Baseline to 3 months
DFI_6
Time Frame: Change in DNA Fragmentation Index from Baseline to 6 months
6_month_change_DNA Fragmentation Index assessed by Sperm Chromatin Structure Assay
Change in DNA Fragmentation Index from Baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentration_3
Time Frame: Change in sperm concentration from baseline to 3 months in millions/mL
Change sperm concentration 3 months
Change in sperm concentration from baseline to 3 months in millions/mL
Concentration_6
Time Frame: Change in sperm concentration from baseline to 6 months in millions/mL
Change sperm concentration 6 months
Change in sperm concentration from baseline to 6 months in millions/mL
Motility_3
Time Frame: Change in sperm motility from baseline to 3 months in %
Change sperm motility 3 months
Change in sperm motility from baseline to 3 months in %
Motility_6
Time Frame: Change in sperm motility from baseline to 6 months in %
Change sperm motility 6 months
Change in sperm motility from baseline to 6 months in %
Morphology_3
Time Frame: Change in sperm morphology from baseline to 3 months in %
Change sperm morphology 3 months
Change in sperm morphology from baseline to 3 months in %
Morphology_6
Time Frame: Change in sperm morphology from baseline to 6 months in %
Change sperm morphology 6 months
Change in sperm morphology from baseline to 6 months in %

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Q-Pharma
Octean

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Androferti

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Plan to share IPD has not yet been discussed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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