Covid19 Clinical Trial
Official title:
Does COVID-19 Worsen the Semen Parameters? Early Results of a Tertiary Health Center
NCT number | NCT04643522 |
Other study ID # | E1-20-1237 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 7, 2020 |
Est. completion date | October 10, 2020 |
Verified date | November 2020 |
Source | Ankara City Hospital Bilkent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Coronavirus Disease-19 (COVID-19) is a global pandemics which affects many organs and systems with a range of morbidities and high mortality rates. There are a number of studies revealed that COVID-19 may affect the testes and male genital tract which may in turn disrupt the gonadal functions.The current study aimed to evaluate the effect of COVID-19 on semen parameters and sex-related hormone levels.
Status | Completed |
Enrollment | 21 |
Est. completion date | October 10, 2020 |
Est. primary completion date | October 5, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: Reproductive age Infertile men Clinically confirmed (with reverse transcriptase polymerase chain reaction-RT PCR) COVID-19 history Semen analyses performed before and after the diagnosis of COVID-19 (must be applicable for all patients) Sex-related hormone levels including FSH, LH, and T which were reported before and after the diagnosis of COVID-19 (was applicable for some of the patients) Exclusion Criteria: Azoospermia Semen analyses performed only before or after the diagnosis of COVID-19 Semen analysis performed in another hospital RT-PCR results which were reported in another hospital Chronical renal disease Chronical liver failure Patient age lower than 18 years old |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara City Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara City Hospital Bilkent |
Turkey,
Achua JK, Chu KY, Ibrahim E, Khodamoradi K, Delma KS, Iakymenko OA, Kryvenko ON, Arora H, Ramasamy R. Histopathology and Ultrastructural Findings of Fatal COVID-19 Infections on Testis. World J Mens Health. 2020 Nov 3. doi: 10.5534/wjmh.200170. [Epub ahea — View Citation
Holtmann N, Edimiris P, Andree M, Doehmen C, Baston-Buest D, Adams O, Kruessel JS, Bielfeld AP. Assessment of SARS-CoV-2 in human semen-a cohort study. Fertil Steril. 2020 Aug;114(2):233-238. doi: 10.1016/j.fertnstert.2020.05.028. Epub 2020 May 29. — View Citation
Ma L, Xie W, Li D, Shi L, Ye G, Mao Y, Xiong Y, Sun H, Zheng F, Chen Z, Qin J, Lyu J, Zhang Y, Zhang M. Evaluation of sex-related hormones and semen characteristics in reproductive-aged male COVID-19 patients. J Med Virol. 2020 Jul 4. doi: 10.1002/jmv.262 — View Citation
Yang M, Chen S, Huang B, Zhong JM, Su H, Chen YJ, Cao Q, Ma L, He J, Li XF, Li X, Zhou JJ, Fan J, Luo DJ, Chang XN, Arkun K, Zhou M, Nie X. Pathological Findings in the Testes of COVID-19 Patients: Clinical Implications. Eur Urol Focus. 2020 Sep 15;6(5):1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Semen analyses parameters including sperm motility (total, progressive, non-progressive and immotile | cell count percentage | first 1 hour | |
Primary | Semen analyses parameters including sperm concentration | cell count per milliliters of semen sample. | first 1 hour | |
Primary | Semen analyses parameters including sperm morphology | percentage of normal forms | first 1 hour | |
Primary | Semen analyses parameters including semen volume | milliliters | first 1 hour | |
Secondary | Sex-related hormone levels including testosterone | nanograms per deciliter | 20 minutes | |
Secondary | Sex-related hormone levels including follicle stimulating hormone and luteinizing hormone | Units per liter | 20 minutes |
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