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

Phase 4

Completed

• Conditions: Infertility; Male; Oligoasthenozoospermia
• Interventions: Combination Product: Antioxidant formula

• Registration Number: NCT05135143
• Lead Sponsor: University of Tetova

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.

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:

1. Identifying new cases and taking measures early, in order to overcome fertilization problems;

2. For the first time in North Macedonia there will be a more accurate picture of the prevalence of male infertility;

3. Expanding current scientific knowledge about the role of oxidative stress, its laboratory evaluation, and the impact of antioxidant supplements;

4. 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;

5. 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;

6. 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 Timeline

• Study Start: 2017-09-01
• Primary Completion: 2019-06-30
• Study Completion: 2021-01-31
• Study First Submitted: 2021-10-25
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-13
• Study First Posted: 2021-11-26
• Last Update Submitted: 2021-11-27
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 211

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infertility male patients	Antioxidant formula	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.
Control group	Antioxidant formula	Placebo treatment and control and comparative variables will be measured.

Primary Outcome Measures

Name	Time	Method
Sperm parameters	6 months	Motility (percentage)

Secondary Outcome Measures

Name	Time	Method
oxidative stress parameters	6 months	TAC (IU/ml)

Trial Locations

Locations (1)

Univeristy of Tetova; 🇲🇰 Tetovo, North Macedonia