Impact of Coenzyme Q10 and Selenium on Seminal Fluid and Semen Antioxidant Status

NCT03834831 | Completed

• 1 other identifier: EC/2018/8866
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men.

Conditions

Male Infertility

Keywords

Male infertility; Coenzyme Q10; Selenium; Antioxidants

Outcome Measures

Primary Outcomes (7)

• Semen volume (WHO 2010 guidelines)

  Semen volume in ml

  3 months

• Sperm concentration in semen (WHO 2010 guidelines)

  Sperm concentration in million/ml

  3 months

• Sperm motility in semen (WHO 2010 guidelines)

  Sperm motility (%)

  3 months

• Sperm morphology in semen (WHO 2010 guidelines)

  Normal sperm morphology (%)

  3 months

• Seminal plasma TAC (Colorimetric assays)

  Seminal plasma total antioxidant capacity in mmol/ml

  3 months

• Seminal plasma CAT (Colorimetric assays)

  Seminal plasma catalase in U/ml

  3 months

• Seminal plasma SOD (Colorimetric assays)

  Superoxide dismutase in U/ml

  3 months

Study Arms (2)

Coenzyme Q10

ACTIVE COMPARATOR

Coenzyme Q10 200mg/day for 3 months

Dietary Supplement: Coenzyme Q10

Selenium

ACTIVE COMPARATOR

Selenium mcg/day for 3 months

Dietary Supplement: Selenium

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

Coenzyme Q10

Coenzyme Q10

Selenium DIETARY_SUPPLEMENT

Selenium

Selenium

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male infertility
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of infertility of at least 12 months despite regular unprotected intercourse.
• Oligoasthenoteratospermia was diagnosed by semen analysis showing abnormal sperm concentration (\<15 million/ml), progressive motility (\<32%), total motility (\<40%) and morphology (\<30% WHO criteria) as defined by WHO manual for semen analysis 2010

You may not qualify if:

• Azoospermia,
• Varicocele,
• Genital tract infection,
• Cryptorchidism,
• Testicular trauma or scrotal surgery,
• Endocrine disorder,
• Systemic illness,
• Smoking
• The presence of female factor

Sponsors & Collaborators

• University of Sumer: lead

Study Sites (1)

Fertility Unit, Babyl

Hillah, 00964, Iraq

Location

Related Publications (2)

• Alshahrani S, Aldossari K, Al-Zahrani J, Gabr AH, Henkel R, Ahmad G. Interpretation of semen analysis using WHO 1999 and WHO 2010 reference values: Abnormal becoming normal. Andrologia. 2018 Mar;50(2). doi: 10.1111/and.12838. Epub 2017 Aug 3.

  PMID: 28771785 BACKGROUND

• Alahmar AT. The effects of oral antioxidants on the semen of men with idiopathic oligoasthenoteratozoospermia. Clin Exp Reprod Med. 2018 Jun;45(2):57-66. doi: 10.5653/cerm.2018.45.2.57. Epub 2018 Jun 29.

  PMID: 29984205 BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Interventions

coenzyme Q10; Selenium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Ahmed T Alahmar

  University of Sumer, Iraq

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: June 1, 2018
• Primary Completion: October 31, 2018
• Study Completion: January 10, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)