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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03834831
Other study ID # EC/2018/8866
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date January 10, 2019

Study information

Verified date March 2019
Source University of Sumer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date January 10, 2019
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Coenzyme Q10
Coenzyme Q10
Selenium
Selenium

Locations

Country Name City State
Iraq Fertility Unit, Babyl Hilla

Sponsors (1)

Lead Sponsor Collaborator
University of Sumer

Country where clinical trial is conducted

Iraq, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Semen volume (WHO 2010 guidelines) Semen volume in ml 3 months
Primary Sperm concentration in semen (WHO 2010 guidelines) Sperm concentration in million/ml 3 months
Primary Sperm motility in semen (WHO 2010 guidelines) Sperm motility (%) 3 months
Primary Sperm morphology in semen (WHO 2010 guidelines) Normal sperm morphology (%) 3 months
Primary Seminal plasma TAC (Colorimetric assays) Seminal plasma total antioxidant capacity in mmol/ml 3 months
Primary Seminal plasma CAT (Colorimetric assays) Seminal plasma catalase in U/ml 3 months
Primary Seminal plasma SOD (Colorimetric assays) Superoxide dismutase in U/ml 3 months
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