Clinical trial NCT03850561: Effect of Two Doses of Coenzyme Q10 on Seminal Fluid and Semen Antioxidant Status
Official title: The Effect of Two Doses of Coenzyme Q10 on Seminal Fluid Parameters and Antioxidant Status: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: Male infertility
Coenzyme Q10
Antioxidants
Lead sponsor: University of Sumer
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The study was conducted to assess the impact of two doses of coenzyme Q10 on seminal fluid parameters and antioxidant status in infertile men.

Detailed description: The aim of this study was to assess the impact of two doses of coenzyme Q10 on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Semen volume (WHO 2010 guidelines)
timeFrame: 3 months
measure: Sperm concentration in semen (WHO 2010 guidelines)
timeFrame: 3 months
measure: Sperm motility in semen (WHO 2010 guidelines)
timeFrame: 3 months
measure: Sperm morphology in semen (WHO 2010 guidelines)
timeFrame: 3 months
measure: Seminal plasma TAC
timeFrame: 3 months
measure: Seminal plasma CAT
timeFrame: 3 months
measure: Seminal plasma SOD
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hilla
country: Iraq
facility: Fertility Unit, Babyl
Study officials:
affiliation: University of Sumer, Iraq
name: Ahmed T Alahmar, MBChB, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Nadjarzadeh A, Shidfar F, Amirjannati N, Vafa MR, Motevalian SA, Gohari MR, Nazeri Kakhki SA, Akhondi MM, Sadeghi MR. Effect of Coenzyme Q10 supplementation on antioxidant enzymes activity and oxidative stress of seminal plasma: a double-blind randomised clinical trial. Andrologia. 2014 Mar;46(2):177-83. doi: 10.1111/and.12062. Epub 2013 Jan 7.