NCT05135143

Brief Summary

Numerous studies verify that the majority of cases of male infertility belong to the group diagnosed with oligoasthenoteratozoospermia (OAT), which means a decrease in the number of sperm in the ejaculate to 15 million / ml, reduced sperm motility of the spermatozoa and morphological disorders of the neck or tail of the sperm. Genuine scientific studies can not pinpoint the cause of these changes, however, recent advances in science shed light on this issue by confirming the reason, which is as a result of the action of free radicals - oxidative stress.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

October 25, 2021

Last Update Submit

November 27, 2021

Conditions

InfertilityOligoasthenozoospermiaMale

Keywords

antioxidantoxidative stresssperm parametersMalonedialdehydetotal antioxidant capacity

Outcome Measures

Primary Outcomes (3)

  • Sperm parameters

    Concentration (10x6 ml)

    6 months

  • Sperm parameters

    Morphology (percentage)

    6 months

  • Sperm parameters

    Motility (percentage)

    6 months

Secondary Outcomes (3)

  • oxidative stress parameters

    6 months

  • oxidative stress parameters

    6 months

  • oxidative stress parameters

    6 months

Study Arms (2)

Infertility male patients

ACTIVE COMPARATOR

Infertile male patients will receive the antioxidant formula for more than 172 days. Divided in two groups. One will take the active substance, to the other group placebo treatment will be given.

Combination Product: Antioxidant formula

Control group

PLACEBO COMPARATOR

Placebo treatment and control and comparative variables will be measured.

Combination Product: Antioxidant formula

Interventions

Antioxidant formulaCOMBINATION_PRODUCT

Administration of antioxidant formula 3 times a day and once daily.

Control groupInfertility male patients

Eligibility Criteria

Age19 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBecause investigators have to measure sperm parameters
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age, 19-45 years;
  • infertility, 2 years;
  • regular sexual intercourse with a fertile female.
  • The female partner was defined as being fertile if she had undergone a negative infertility workup (biphasic basal body temperature, P evaluation in luteal phase, ultrasound ovary and uterus evaluation, and hysterosalpingogram to study tubal patency)

You may not qualify if:

  • a history of excessive consumption of alcohol 40 days prior to the start of the trial,
  • patients that showed lower than 5% motility and less than 1 × 106/ml sperm concentration, - patients with any acute or chronic disease or
  • who are undergoing some kind of treatment with any class of drugs and
  • subjects with known hypersensitivity to ingredients in the antioxidant formula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Tetova

Tetovo, 6338, North Macedonia

Location

Related Publications (5)

  • Vegim Zhaku, Ashok Agarwal, Sheqibe Beadini, Ralf Henkel, Renata Finelli, Nexhbedin Beadini and Sava Micic (June 8th 2021). Male Infertility, Oxidative Stress and Antioxidants, Vitamin E in Health and Disease - Interactions, Diseases and Health Aspects, Pınar Erkekoglu and Júlia Scherer Santos, IntechOpen, DOI: 10.5772/intechopen.98204. Available from: https://www.intechopen.com/chapters/77097

    BACKGROUND

  • ] Zhaku V, Beadini Sh, Beadini N, Xhaferi V, Golaboska J. The role of semen analysis in the expression of male infertility in southwestern part of North Macedonia (Experiences from 7 municipalities). UNIVERSI-International Journal of Education Science Technology Innovation Health and Enviroment. 2019;5(2):96-104.

    BACKGROUND

  • Zhaku V, Beadini Sh, Beadini N, Murtezani B. Combination of Maca, Korean ginseng extract and antioxidant therapy for male with oligoasthenozoospermia: case study. Journal of Hygienic Engineering and Design. 2019; 26(1):28-35.

    BACKGROUND

  • Zhaku V, Beadini Sh, Beadini N, Xhaferi V. Role of antioxidants in the diminution of oxidative stress and amelioration of semen parameters in idiopathic male infertility. Acta Medica Balkanica. 2020; 5(9-10):69-80.

    BACKGROUND

  • Zhaku V, Beadini Sh, Beadini N, Xhaferi V, Milenkovic T. Oral antioxidants improve sperm motility, sperm concentration and reduce oxidative stress in males with oligo-asthenozoospermia. In: 22nd European Congress of Endocrinology; 5-9 September 2020; Prague, Czech Republic: Endocrine Abstracts (2020) 70 EP581. DOI:10.1530/ endoabs.70.EP581

    BACKGROUND

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Vegim Zhaku, MD, PhDc

    University of Tetova

    PRINCIPAL INVESTIGATOR

  • Sheqibe Beadini, PhD

    University of Tetova

    STUDY CHAIR

  • Nexhbedin Beadini, PhD

    Univeristy of Tetova

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Double blind randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor and Teaching assistant

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 26, 2021

Study Start

September 1, 2017

Primary Completion

June 30, 2019

Study Completion

January 31, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

NO(1)