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Sperm Count, LowNCT04643522

Semen Parameters and COVID-19 in Infertile Men

An observational study of Sperm Count, Low and Hormone Disturbance, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, men only
Conditions the study is for
Sperm Count, Low, Hormone Disturbance, Covid19
What is being tested?
Clinical assessment
How many people
21 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Jan 2020to 10 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara City Hospital

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Clinical assessment
Keywords
COVID-19, Male infertility, Semen parameters, Sex-related hormone levels
Medical subject headings
Oligospermia, Endocrine System Diseases, COVID-19, Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical assessmentOther

    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).

Study groups in NCT04643522
Study groupRoleWhat they receive
Before COVID-19The semen parameters and sex-related hormone levels of the patients which were performed before the diagnosis of COVID-19.
Receives: Other: Clinical assessment
After COVID-19The semen parameters and sex-related hormone levels of the patients which were performed after the diagnosis of COVID-19.
Receives: Other: Clinical assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    cell count percentage

    Measured: first 1 hour

  2. Semen analyses parameters including sperm concentration

    cell count per milliliters of semen sample.

    Measured: first 1 hour

  3. Semen analyses parameters including sperm morphology

    percentage of normal forms

    Measured: first 1 hour

  4. Semen analyses parameters including semen volume

    milliliters

    Measured: first 1 hour

Secondary outcomes (2)

  1. Sex-related hormone levels including testosterone

    nanograms per deciliter

    Measured: 20 minutes

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

    Units per liter

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2020
  2. Study start7 Jan 2020
  3. Primary completion5 Oct 2020
  4. Study completion10 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04643522
Sponsor's protocol ID
E1-20-1237
Status last verified
Nov 2020
First submitted
24 Nov 2020
Last updated
30 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data belonging to participants will be available to any researcher or editorial reviewer board if needed.

Publications

  • Holtmann N, Edimiris P, Andree M, Doehmen C, Baston-Buest D, Adams O, Kruessel JS, Bielfeld AP. Assessment of SARS-CoV-2 in human semen-a cohort study. Fertil Steril. 2020 Aug;114(2):233-238. doi: 10.1016/j.fertnstert.2020.05.028. Epub 2020 May 29.

    PubMed 32650948

  • Ma L, Xie W, Li D, Shi L, Ye G, Mao Y, Xiong Y, Sun H, Zheng F, Chen Z, Qin J, Lyu J, Zhang Y, Zhang M. Evaluation of sex-related hormones and semen characteristics in reproductive-aged male COVID-19 patients. J Med Virol. 2021 Jan;93(1):456-462. doi: 10.1002/jmv.26259. Epub 2020 Jul 19.

    PubMed 32621617

  • Achua JK, Chu KY, Ibrahim E, Khodamoradi K, Delma KS, Iakymenko OA, Kryvenko ON, Arora H, Ramasamy R. Histopathology and Ultrastructural Findings of Fatal COVID-19 Infections on Testis. World J Mens Health. 2021 Jan;39(1):65-74. doi: 10.5534/wjmh.200170. Epub 2020 Nov 3.

    PubMed 33151050

  • Yang M, Chen S, Huang B, Zhong JM, Su H, Chen YJ, Cao Q, Ma L, He J, Li XF, Li X, Zhou JJ, Fan J, Luo DJ, Chang XN, Arkun K, Zhou M, Nie X. Pathological Findings in the Testes of COVID-19 Patients: Clinical Implications. Eur Urol Focus. 2020 Sep 15;6(5):1124-1129. doi: 10.1016/j.euf.2020.05.009. Epub 2020 May 31.

    PubMed 32563676

Questions about this trial

What is this clinical trial studying?

An observational study of Sperm Count, Low and Hormone Disturbance, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Semen analyses parameters including sperm motility (total, progressive, non-progressive and immotile (time frame: first 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04643522, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.

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