LOng COvid COmorbidities: Andrological, Reproductive, Sexual Dysfunctions in Patients Recovered From COVID-19
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|ClinicalTrials.gov Identifier: NCT05379556|
Recruitment Status : Recruiting
First Posted : May 18, 2022
Last Update Posted : May 26, 2022
|Condition or disease||Intervention/treatment|
|Long Covid-19||Diagnostic Test: Assessment of andrological profile of LO-COCO-ANDRO male patients Diagnostic Test: Assessment of reproductive function of LO-COCO-ANDRO male patients Diagnostic Test: Assessment of sexual function of LO-COCO-ANDRO male patients Diagnostic Test: Assessment of olfactory function of LO-COCO-ANDRO male and female patients|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||LOng COvid COmorbidities: Evaluation of Andrological, Reproductive and Sexual Functions in Patients Recovered From COVID-19|
|Actual Study Start Date :||January 27, 2022|
|Estimated Primary Completion Date :||January 27, 2024|
|Estimated Study Completion Date :||January 27, 2024|
- Diagnostic Test: Assessment of andrological profile of LO-COCO-ANDRO male patients
Assessment of serum prolactin (PRL), luteininzing hormone (LH), follicle stimulating hormone (FSH), 17β-estradiol, testosterone. Physical examination with measurement of body weight, height, body mass index, waist and hip circumference. Andrological physical examination with evaluation of testis volume with Prader orchidometer, testicular consistency and lesions, varicocele. Scrotal ultrasound performed in longitudinal, transverse and oblique scans using a high frequency linear probe with grayscale and color-doppler; transrectal prostate ultrasound performed with transverse, longitudinal and oblique scans using an "end fire" probe; basal penile ultrasound will be performed in longitudinal and transverse scans using a high frequency linear probe with grayscale and color-doppler; dynamic penile ultrasound performed as described for basal penile ultrasound after intra-cavernous infiltration of 10 mcg of prostaglandin-E1 (PGE1).
- Diagnostic Test: Assessment of reproductive function of LO-COCO-ANDRO male patients
Semen samples will be collected on site by masturbation directly into a sterile plastic container after 3-5 days of sexual abstinence. The sample will be analyzed according to World Health Organization (WHO) 2010 guidelines. Semen samples will be stored for biochemical and molecular evaluations.
- Diagnostic Test: Assessment of sexual function of LO-COCO-ANDRO male patients
Validated questionnaires to assess the prevalence of male sexual disorders, namely erectile dysfunction with International Index of Erectile function 15 (IIEF-15), premature ejaculation with premature ejaculation diagnostic tool (PEDT), hypoactive sexual desire disorder with andrological structured interview on erectile dysfunction (ANDRO-SIEDY). Patients will be also interviewed to evaluate lifestyle habits.
- Diagnostic Test: Assessment of olfactory function of LO-COCO-ANDRO male and female patients
Brief interview to collect patient's anamnesis relative to olfactory function, with particular reference to hypo / anosmia and hypo/ageusia onset timeline, duration and regression.
Interview for the self-assessment of chemosensory skills and for the evaluation of quality of life in relation to olfactory dysfunction.
Sniffin 'Sticks test for the evaluation of odor threshold (T), odor discrimination (D) and odor identification (I) (TDI score).
- Identification of the most frequent phenotypes of Long-COVID syndrome among COVID-19 patients recently hospitalized and dismissed [ Time Frame: Change from baseline at 3-12 months ]This pilot study will allow identifying the frequency and type of andrological, reproductive, sexual and olfactory disorders that contribute to the long covid syndrome.
- Number of patients with andrological dysfunctions [ Time Frame: Change from baseline at 3-12 months ]Prevalence of andrological dysfunctions (hypogonadism, morpho-structural alterations of the testis including testicular hypotrophy, testicular and / or epididymal inhomogeneity, testicular calcifications / microlithiasis, testicular solid lesions, hydrocele, varicocele, altered testicular and / or epididymal vascularization, prostate-vesicular morpho-structural alterations, morpho-structural and hemodynamic alterations of the penis including nodules, alterations of the albuginea tunic, presence of fibrotic or calcified plaques, morphological and haemodynamic alterations of the cavernous arteries, anastomosis between the cavernous arteries and the dorsal artery, collateral circulation, occlusions).
- Number of patients with reproductive dysfunctions [ Time Frame: Change from baseline at 3-12 months ]Prevalence of male reproductive dysfunctions: alterations of seminal parameters (oligo-, astheno-, teratozoospermia, azoospermia, necrozoospermia, leukocytospermia, hypo / hyperposia).
- Number of patients with sexual dysfunctions [ Time Frame: Change from baseline at 3-12 months ]Prevalence of male sexual dysfunctions (erectile dysfunction, premature ejaculation, hypoactive sexual desire disorder).
- Number of patients with olfactory dysfunctions [ Time Frame: Change from baseline at 3-12 months ]Prevalence of olfactory dysfunctions (hypo/anosmia and hypo/ageusia) in male and female patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05379556
|Contact: Rosario Pivonello, Prof.||firstname.lastname@example.org|
|Federico II University of Naples||Recruiting|
|Naples, Italy, 80131|
|Contact: Rosario Pivonello, Prof. 3317328474 email@example.com|
|Principal Investigator:||Rosario Pivonello, Prof.||Federico II University|