Administration of Antioxidants to Infertile Men and Sperm Quality

NCT04256278 | Completed

• 1 other identifier: UHR-15
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized clinical trial is to assess the effect of oral antioxidant administration to infertile men, by evaluating semen variables, sperm DFI and levels of ROS. Oral antioxidants or placebo will be given for 3 consecutive months. The study will recruit infertile men, who have one previous abnormal spermiogram, with at least one pathological variable (concentration, motility, morphology), according to WHO 2010 criteria. Participants will be recruited in the outpatient clinic of the Unit of Human Reproduction and of the Unit of Reproductive Endocrinology at the 1st Ob/Gyn Dept.

Conditions

Male Infertility

Keywords

sperm; infertility; asthenospermia; oligospermia; teratozoospermia; antioxidants

Outcome Measures

Primary Outcomes (2)

• Sperm parameters

  Sperm motility(Sperm motility was classified using a four-category scheme: A:rapid progressive, B:slow progressive, C:non-progressive, and D:immotile , %A+B, normal values \>32% A+B)

  immediately before treatment initiation

• Sperm parameters

  Sperm motility(Sperm motility was classified using a four-category scheme: A:rapid progressive, B:slow progressive, C:non-progressive, and D:immotile , %A+B, normal values \>32% A+B)

  immediately after the end of a 3 month treatment

Secondary Outcomes (8)

• Reactive Oxygen Species (ROS)

  immediately before treatment initiation

• Reactive Oxygen Species (ROS)

  immediately after the end of a 3 month treatment

• DNA fragmentation Index (DFI)

  immediately before treatment initiation

• DNA fragmentation Index (DFI)

  immediately after the end of a 3 month treatment

• Sperm parameters

  immediately before treatment initiation

Study Arms (2)

Intervention Group

EXPERIMENTAL

Other: Spermotrend

Control Group

PLACEBO COMPARATOR

Other: Spermotrend

Interventions

Spermotrend OTHER

oral administration of antioxidants for three months

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men, 18-50 years old
• Infertility defined as follows:
• Failure to obtain a pregnancy after at least twelve (12) months of regular sexual intercourse without the use of contraceptives or six (6) months if the woman is\> 35 years old AND
• At least one previous abnormal spermiogram, with at least one pathological parameter (concentration, motility, morphology), according to the WHO 2010 criteria.
• No treatment for infertility in the last three (3) months
• Normal hormone profile (TSH, FSH, LH, total testosterone, prolactin)
• Negative culture for mycoplasma or ureaplasma
• Physiological scrotal ultrasound

You may not qualify if:

• Genetic cause of infertility
• History of cryptorchidism
• History of orchectomy
• History of testicular cancer
• History of severe heart, liver or kidney disease
• History of endocrine disease (primary or secondary hypogonadism, hyperprolactinemia, thyroid, pituitary or adrenal disease)
• History of systemic disease or treatment in the last three (3) months
• BMI \> 30 kg/m2
• Participation in another study and the possibility of the patient not being available for follow-up

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Andrology lab Zeginiadou: collaborator
• Armatura: collaborator

Study Sites (1)

Unit of Assisted Reproduction, 1st Department of Obstetrics-Gynecology -Papageorgiou General Hospital, Thessaloniki, Greece

Thessaloniki, Central Makedonia, 56403, Greece

Location

Related Publications (5)

• Majzoub A, Agarwal A. Systematic review of antioxidant types and doses in male infertility: Benefits on semen parameters, advanced sperm function, assisted reproduction and live-birth rate. Arab J Urol. 2018 Jan 2;16(1):113-124. doi: 10.1016/j.aju.2017.11.013. eCollection 2018 Mar.

  PMID: 29713542 RESULT

• Agarwal A, Virk G, Ong C, du Plessis SS. Effect of oxidative stress on male reproduction. World J Mens Health. 2014 Apr;32(1):1-17. doi: 10.5534/wjmh.2014.32.1.1. Epub 2014 Apr 25.

  PMID: 24872947 RESULT

• Chen SJ, Allam JP, Duan YG, Haidl G. Influence of reactive oxygen species on human sperm functions and fertilizing capacity including therapeutical approaches. Arch Gynecol Obstet. 2013 Jul;288(1):191-9. doi: 10.1007/s00404-013-2801-4. Epub 2013 Mar 30.

  PMID: 23543240 RESULT

• Tremellen K. Oxidative stress and male infertility--a clinical perspective. Hum Reprod Update. 2008 May-Jun;14(3):243-58. doi: 10.1093/humupd/dmn004. Epub 2008 Feb 14.

  PMID: 18281241 RESULT

• Zini A, San Gabriel M, Baazeem A. Antioxidants and sperm DNA damage: a clinical perspective. J Assist Reprod Genet. 2009 Aug;26(8):427-32. doi: 10.1007/s10815-009-9343-5. Epub 2009 Sep 19.

  PMID: 19768529 RESULT

MeSH Terms

Conditions

Infertility, Male; Infertility; Asthenozoospermia; Oligospermia; Teratozoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stratis Kolibianakis, Professor

  Aristotle University Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: use of placebo, masked randomization list
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Obstetrics and Gynecology and Assisted Reproduction

Model Details: quadruple-blind study

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: February 5, 2020
• Study Start: February 28, 2020
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

GR (1)