Semen Parameters and COVID-19 in Infertile Men

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Completed

CT.gov ID

NCT04643522

Collaborator

(none)

Enrollment

Location

9.1

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sperm Count, Low Hormone Disturbance Covid19	Other: Clinical assessment

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

21 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 7, 2020

Actual Primary Completion Date :

Oct 5, 2020

Actual Study Completion Date :

Oct 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Before COVID-19 The semen parameters and sex-related hormone levels of the patients which were performed before the diagnosis of COVID-19.	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).
After COVID-19 The semen parameters and sex-related hormone levels of the patients which were performed after the diagnosis of COVID-19.	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).

Arm

Intervention/Treatment

Before COVID-19

The semen parameters and sex-related hormone levels of the patients which were performed before the diagnosis of COVID-19.

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).

After COVID-19

The semen parameters and sex-related hormone levels of the patients which were performed after the diagnosis of COVID-19.

Other: Clinical assessment

Outcome Measures

Primary Outcome Measures

Semen analyses parameters including sperm motility (total, progressive, non-progressive and immotile [first 1 hour]
cell count percentage
Semen analyses parameters including sperm concentration [first 1 hour]
cell count per milliliters of semen sample.
Semen analyses parameters including sperm morphology [first 1 hour]
percentage of normal forms
Semen analyses parameters including semen volume [first 1 hour]
milliliters

Secondary Outcome Measures

Sex-related hormone levels including testosterone [20 minutes]
nanograms per deciliter
Sex-related hormone levels including follicle stimulating hormone and luteinizing hormone [20 minutes]
Units per liter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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