OAT: Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients

Sponsor

University of Tetova (Other)

Overall Status

Completed

CT.gov ID

NCT05135143

Collaborator

University of Tetova, Faculty of Medical Sciences (Other)

211

Enrollment

Location

Arms

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Oligoasthenozoospermia Male	Combination Product: Antioxidant formula	Phase 4

Detailed Description

The enlightenment project in the field of male infertility in North Macedonia will include a wide team of: students, general practitioners, assistants, professors of pre-clinical subjects, professors and specialists in the field of gynecology, urology and andrologists. The involvement of such a large number of professionals once again verifies the seriousness and determination that this scientific project has.

Investigators hope to contribute generously to:

Identifying new cases and taking measures early, in order to overcome fertilization problems;
For the first time in North Macedonia there will be a more accurate picture of the prevalence of male infertility;
Expanding current scientific knowledge about the role of oxidative stress, its laboratory evaluation, and the impact of antioxidant supplements;
Standardization of doses and type of antioxidant supplements that will be used during the realization of this dissertation and evaluation of their clinical effect in men with OAT;
After the implementation of antioxidant therapy, investigators expect that the results of live births and spontaneous pregnancies will increase, while the number of miscarriages will decrease;
Acquisition of knowledge on laboratory and clinical evaluation techniques of infertile men, which would later lead to the establishment of an andrological laboratory. Investigators anticipate this laboratory to function within the Faculty of Medical Sciences, where all procedures will be performed, from diagnosis to the operation of assisted reproduction techniques (TRA). This, in addition to the material benefit for the benefit of the University of Tetova, also has a benefit in terms of staff, which will be professionalized and trained during the realization of this dissertation.

Study Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind randomizedDouble blind randomized

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Infertility male patients 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 Administration of antioxidant formula 3 times a day and once daily.
Placebo Comparator: Control group Placebo treatment and control and comparative variables will be measured.	Combination Product: Antioxidant formula Administration of antioxidant formula 3 times a day and once daily.

Arm

Intervention/Treatment

Active Comparator: Infertility male patients

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

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

Placebo Comparator: Control group

Placebo treatment and control and comparative variables will be measured.

Combination Product: Antioxidant formula

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

Outcome Measures

Primary Outcome Measures

Sperm parameters [6 months]
Concentration (10x6 ml)
Sperm parameters [6 months]
Morphology (percentage)
Sperm parameters [6 months]
Motility (percentage)

Secondary Outcome Measures

oxidative stress parameters [6 months]
MDA (mg/ml)
oxidative stress parameters [6 months]
Caspase 3 (IU/ml)
oxidative stress parameters [6 months]
TAC (IU/ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

use of antioxidant agents or vitamins within 8 weeks prior to inclusion in the study,
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.