Semen Parameters and COVID-19 in Infertile Men

NCT04643522 | Completed

• 1 other identifier: E1-20-1237
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Sperm Count, Low; Hormone Disturbance; Covid19

Keywords

COVID-19; Male infertility; Semen parameters; Sex-related hormone levels

Outcome Measures

Primary Outcomes (4)

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

  cell count percentage

  first 1 hour

• Semen analyses parameters including sperm concentration

  cell count per milliliters of semen sample.

  first 1 hour

• Semen analyses parameters including sperm morphology

  percentage of normal forms

  first 1 hour

• Semen analyses parameters including semen volume

  milliliters

  first 1 hour

Secondary Outcomes (2)

• Sex-related hormone levels including testosterone

  20 minutes

• Sex-related hormone levels including follicle stimulating hormone and luteinizing hormone

  20 minutes

Study Arms (2)

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

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

Interventions

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).

After COVID-19; Before COVID-19

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32650948 RESULT

• 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.

  PMID: 32621617 RESULT

• 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.

  PMID: 33151050 RESULT

• 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.

  PMID: 32563676 RESULT

MeSH Terms

Conditions

Oligospermia; Endocrine System Diseases; COVID-19; Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Erdem Koç

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: November 25, 2020
• Study Start: January 7, 2020
• Primary Completion: October 5, 2020
• Study Completion: October 10, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)