Assessment of Sexual Dysfunction Among COVID-19 Recovered Patients

NCT05148819 | Unknown

• 1 other identifier: PCSD
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

Covid-19 pandemic has affected hundreds of millions globally(https ://coronavirus.jhu.edu/map.html), and hundreds of thousands in Egypt(https://www.care.gov.eg/EgyptCare/Index.aspx). However, the long-term consequences of the disease are still largely unknown. Data from 2002-2004 epidemics of SARS suggest that cardiovascular sequelae, such as microangiopathy, cardiomyopathy and impaired endothelial function, are to be expected also in COVID-19 patients.(Vittori et al, 2020) Hyperinflammation and immunosuppression are prominently featured in COVID-19, causing a cytokine storm leading to development of micro-thrombosisand disseminated intravascular coagulation (DIC). (Jose et al, 2020). These findings can be extremely relevant for male and female sexual health: indeed, based on these premises, there is quite enough evidence to hypothesize that consequences of COVID-19 can extend to sexual and reproductive health. (Sansone et al, 2020) A self-administered questionnaire will be disseminated using online electronic social network (Facebook, What's App) including: Sociodemographic age\& gender. Sexual dysfunction will be assessed using International Index of Erectile Function-5 (IIEF-5) for males, and Arabic Female Sexual Function Index (ArFSFI) for females will be applied. Covid-19 related factors.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Identification of the prevalence of sexual dysfunction among covid-19 survivors.

  December 2022

Secondary Outcomes (1)

• To evaluate and compare the duration since recovery and sexual dysfunction. 3- To evaluate and compare the duration since recovery and sexual dysfunction. 3- To evaluate and compare the duration since recovery and sexual d

  December 2022

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Was calculated using epi info statistical package version 7. Based on the following parameters for cross sectional study; assumed sexual dysfunction proportion 0.50, acceptable margin of error 0.05, design effect 1, 95% confidence level. The required sample size will be 384 subjects.

You may qualify if:

• \. Age:
• Men: 18-60 years
• Women: 18- 50 years
• \. Marital Status: Married

You may not qualify if:

• Chronic Diseases:
• Patients with known history of any chronic disease

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (6)

• Isidori AM, Pofi R, Hasenmajer V, Lenzi A, Pivonello R. Use of glucocorticoids in patients with adrenal insufficiency and COVID-19 infection. Lancet Diabetes Endocrinol. 2020 Jun;8(6):472-473. doi: 10.1016/S2213-8587(20)30149-2. Epub 2020 Apr 23. No abstract available.

  PMID: 32334645 BACKGROUND

• Vittori A, Lerman J, Cascella M, Gomez-Morad AD, Marchetti G, Marinangeli F, Picardo SG. COVID-19 Pandemic Acute Respiratory Distress Syndrome Survivors: Pain After the Storm? Anesth Analg. 2020 Jul;131(1):117-119. doi: 10.1213/ANE.0000000000004914. No abstract available.

  PMID: 32541584 BACKGROUND

• Jose RJ, Manuel A. COVID-19 cytokine storm: the interplay between inflammation and coagulation. Lancet Respir Med. 2020 Jun;8(6):e46-e47. doi: 10.1016/S2213-2600(20)30216-2. Epub 2020 Apr 27. No abstract available.

  PMID: 32353251 BACKGROUND

• Sun X, Wang T, Cai D, Hu Z, Chen J, Liao H, Zhi L, Wei H, Zhang Z, Qiu Y, Wang J, Wang A. Cytokine storm intervention in the early stages of COVID-19 pneumonia. Cytokine Growth Factor Rev. 2020 Jun;53:38-42. doi: 10.1016/j.cytogfr.2020.04.002. Epub 2020 Apr 25.

  PMID: 32360420 BACKGROUND

• Sansone A, Mollaioli D, Ciocca G, Limoncin E, Colonnello E, Vena W, Jannini EA. Addressing male sexual and reproductive health in the wake of COVID-19 outbreak. J Endocrinol Invest. 2021 Feb;44(2):223-231. doi: 10.1007/s40618-020-01350-1. Epub 2020 Jul 13.

  PMID: 32661947 BACKGROUND

• Lodigiani C, Iapichino G, Carenzo L, Cecconi M, Ferrazzi P, Sebastian T, Kucher N, Studt JD, Sacco C, Bertuzzi A, Sandri MT, Barco S; Humanitas COVID-19 Task Force. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020 Jul;191:9-14. doi: 10.1016/j.thromres.2020.04.024. Epub 2020 Apr 23.

  PMID: 32353746 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

• Sahar Ismaiel, Professor

  Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University

  STUDY DIRECTOR

Central Study Contacts

Reham A Ibrahim, MBBS

CONTACT

1006033730; rehamabdalla@live.com

Aya Y Badran, Lecturer

CONTACT

1013244819; aya_badran@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate student

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 8, 2021
• Study Start: January 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: April 1, 2023
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

EG (1)