Semen Parameters and COVID-19 in Infertile Men

Completed

• Conditions: Sperm Count, Low; Hormone Disturbance; Covid19
• Interventions: Other: Clinical assessment

• Registration Number: NCT04643522
• Lead Sponsor: Ankara City Hospital Bilkent

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.

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 Timeline

• Study Start: 2020-01-07
• Primary Completion: 2020-10-05
• Study Completion: 2020-10-10
• Status Verified: 2020-11
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-11-25
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
After COVID-19	Clinical assessment	The semen parameters and sex-related hormone levels of the patients which were performed after the diagnosis of COVID-19.
Before COVID-19	Clinical assessment	The semen parameters and sex-related hormone levels of the patients which were performed before the diagnosis of COVID-19.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey