An observational study in Sperm Count, Low, Hormone Disturbance and Covid19, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-11-30.
Sponsored by Ankara City Hospital Bilkent · Observational
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.
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.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's enrollment of 21 is below the median of 300 across 17 observational studies indexed under Oligospermia.
Browse Oligospermia studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
The semen parameters and sex-related hormone levels of the patients which were performed before the diagnosis of COVID-19.
Other: Clinical assessment
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).
Semen analyses parameters including sperm motility (total, progressive, non-progressive and immotile
cell count percentage
Time frame: first 1 hour
Semen analyses parameters including sperm concentration
cell count per milliliters of semen sample.
Time frame: first 1 hour
Semen analyses parameters including sperm morphology
percentage of normal forms
Time frame: first 1 hour
Semen analyses parameters including semen volume
milliliters
Time frame: first 1 hour
Sex-related hormone levels including testosterone
nanograms per deciliter
Time frame: 20 minutes
Sex-related hormone levels including follicle stimulating hormone and luteinizing hormone
Units per liter
Time frame: 20 minutes
Plan to share: No — Data belonging to participants will be available to any researcher or editorial reviewer board if needed.
Ran from Jan 2020 to primary completion in Oct 2020, 8 months.
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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