Semen Parameters and COVID-19 in Infertile Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sperm Count, Low, Hormone Disturbance, Covid19

Intervention / Treatment
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* Other: Clinical assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before COVID-19<br>The semen parameters and sex-related hormone levels of the patients which were performed before the diagnosis of COVID-19. | Other: Clinical assessment<br>* 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).<br>|
| After COVID-19<br>The semen parameters and sex-related hormone levels of the patients which were performed after the diagnosis of COVID-19. | Other: Clinical assessment<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen analyses parameters including sperm motility (total, progressive, non-progressive and immotile | cell count percentage | first 1 hour | 
| Semen analyses parameters including sperm concentration | cell count per milliliters of semen sample. | first 1 hour | 
| Semen analyses parameters including sperm morphology | percentage of normal forms | first 1 hour | 
| Semen analyses parameters including semen volume | milliliters | first 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex-related hormone levels including testosterone | nanograms per deciliter | 20 minutes | 
| Sex-related hormone levels including follicle stimulating hormone and luteinizing hormone | Units per liter | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Male infertility, Semen parameters, Sex-related hormone levels