Semen Parameters and COVID-19 in Infertile Men

Covid19 Clinical Trial

Official title:

Does COVID-19 Worsen the Semen Parameters? Early Results of a Tertiary Health Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643522
• Other study ID #: E1-20-1237
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: October 10, 2020

Study information

• Verified date: November 2020
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

In this current study, the investigators aimed to elucidate the alteration in semen parameters of the infertile male patients who had been infected with SARS-CoV-2, through the comparison of the spermiogram results which were reported before and after the diagnosis of COVID-19. The investigators also aimed to evaluate the impact of COVID-19 on the sex-related hormone levels as follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone (T). The current study is conducted in Ankara City Hospital, the highest capacity tertiary health care center of the capital town of Turkey. The study included 21 patients who applied to Ankara City Hospital, Andrology Clinic for male infertility up to 05 October, 2020 and have had the semen analyses reported before and after the clinically confirmed diagnosis of COVID-19 through reverse transcriptase PCR. Besides the semen analyses, 8 of these 21 patients have also the had the reported levels of T, FSH and LH which were also analyzed.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Covid19
• Endocrine System Diseases
• Hormone Disturbance
• Oligospermia
• Sperm Count, Low

Intervention

Other:
• Clinical assessment
Comparison of semen analysis results and sex-related hormone levels between the dependent groups which were defined as before COVID-19 and after COVID-19 (the data of the same patient group were compared as before and after the diagnosis of COVID-19).

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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

Outcome

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