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NCT Number: NCT04643522

Semen Parameters and COVID-19 in Infertile Men

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Assessment

Other

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).

Primary outcomes

  1. Semen analyses parameters including sperm motility (total, progressive, non-progressive and immotile

    Time frame: first 1 hour

    cell count percentage

  2. Semen analyses parameters including sperm concentration

    Time frame: first 1 hour

    cell count per milliliters of semen sample.

  3. Semen analyses parameters including sperm morphology

    Time frame: first 1 hour

    percentage of normal forms

  4. Semen analyses parameters including semen volume

    Time frame: first 1 hour

    milliliters

Secondary outcomes

  1. Sex-related hormone levels including testosterone

    Time frame: 20 minutes

    nanograms per deciliter

  2. Sex-related hormone levels including follicle stimulating hormone and luteinizing hormone

    Time frame: 20 minutes

    Units per liter

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2020
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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