Semen Parameters and COVID-19 in Infertile Men

November 25, 2020 updated by: Erdem Koç, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The data of overall 25 patients who applied to our clinic for infertility evaluation and have had the semen analysis results reported before, and after the diagnosis of COVID-19 were reviewed. The 4 of the patients were found to have azoospermia. Due to the difficulty to compare the change at semen parameters in case of azoospermia as before and after results, these 4 patients were excluded. The study included 21 patients in final analyses. The results were presented through the two dependent group analyses, based on the patients' data collected before and after the diagnosis of COVID-19.

The diagnosis of COVID-19 had been established according to the detection of SARS-CoV-2 in the sample taken from nasopharynx with a cotton swap, which was examined through the RT-PCR. None of the patients were at active phase of the COVID-19 at time of the semen sampling.The serum samples for hormone analyses were obtained on the same days with the semen samplings.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Erdem Koç, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2020

Primary Completion (ACTUAL)

October 5, 2020

Study Completion (ACTUAL)

October 10, 2020

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (ACTUAL)

November 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-20-1237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data belonging to participants will be available to any researcher or editorial reviewer board if needed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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