CClinicalTrials.gg
Status unknownNCT05148819Updated Dec 8, 2021

Assessment of Sexual Dysfunction Among COVID-19 Recovered Patients

An observational study in COVID-19, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-08.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
384
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

The pandemic of coronavirus disease (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents a first-time challenge for healthcare. Despite of social distancing and isolation measures, the number of affected patients is growing daily. (Isidori et al, 2020) As of November 14th , 2021, more than 253.2 million COVID-19 cases have been confirmed worldwide, with more than 5 million deaths\& more than 229.3 million subjects have recovered from COVID-19 worldwide. (https ://coronaviru s.jhu.edu/map.html)

While in Egypt more than 343 thousand COVID-19 cases with more than 19 thousand deaths have been confirmed\& more than 282 thousand recoveries. (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)

This cytokine storm is strongly associated with the development of interstitial pneumonia (IP), however, although lungs are the primarily targeted organs, the cardiovascular system is globally affected.(Sun X et al, 2020)

Evidence in this regard supports the notion that the exaggerated production of early response proinflammatory cytokines, increases the risk of vascular hyperpermeability,possibly progressing to multiple organ failure and,ultimately, death.(Sansone et al, 2020)

Additionally, both venous and arterial thromboembolic complications as deep venous thrombosis (DVT) and stroke, including endothelial inflammation, have been reported. (Lodigiani et al, 2020)

Indeed, a growing body of evidence seems to support the theory that the endothelium is targeted by the SARS-CoV-2; (Sardu et al, 2020) most importantly, the endothelium expresses the protein angiotensin-converting enzyme 2 (ACE2),through which the virus can access host cells. (Zhang et al, 2020)

Endothelial dysfunctions, therefore, a pivotal determinant of COVID-19symptoms. (Jung 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)

There is very limited literature on the incidence of sexual dysfunctions, particularly in women.(McCabe et al, 2016)

Studies on the incidence of sexual dysfunction in women are scarce and there is a deficiency of data available on this topic. In a recent study from the United Kingdom, Burri and Spector found that 5.8% of women reported symptoms that constituted a diagnosis of Female Sexual Dysfunction(FSD) and15.5% reported lifelong FSD.

There are few epidemiologic surveys addressing the incidence,as opposed to prevalence, of sexual disorders in men and there are large differences among existing studies. These differences can be explained by variations in study design, populations studied, and definitions of sexual dysfunctions. Because of these variations, itis impossible to specify the incidence of sexual dysfunctions inmen. Most research has been conducted on Erectile Dysfunction(ED). The most important common theme of the studies is that the incidence of sexual dysfunctions increases with age. (McCabe et al, 2016)

A self-administered questionnaire will be disseminated using online electronic social network (Facebook, What's App) including:

  1. Sociodemographic age\& gender.
  2. 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.
  3. Covid-19 related factors:

    1. Duration of infection
    2. Fever
    3. Duration since recovery (in months)
    4. Diagnosis done by (PCR, rapid test, other)
    5. Complications (respiratory, vascular, cardiac, other)
    6. Quarantine (ICU, hospital, home, other)
    7. Positive family of positive COVID-19
    8. Spouse's sexual function
    9. Anticoagulants and antiplatelets
02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 384 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

    1. Age:

      1. Men: 18-60 years
      2. Women: 18- 50 years

        1. Marital Status: Married

Exclusion criteria

Exclusion Criteria:

Chronic Diseases:

Patients with known history of any chronic disease

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
384 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: December 2022

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 32334645 ↗
  • 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. PubMed 32541584 ↗
  • 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. PubMed 32353251 ↗
  • 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. PubMed 32360420 ↗
  • 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. PubMed 32661947 ↗
  • 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. PubMed 32353746 ↗

Individual participant data

Plan to share: Undecided — anonymous questionnaire to evaluate the effect of COVID-19 recovered patients on their sexual function.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05148819
Lead sponsor
Assiut University
Responsible party
Reham Abdalla Ibrahim (Post graduate student, Assiut University) — Principal investigator
First posted
Dec 8, 2021
Start date
Jan 1, 2022 (estimated)
Primary completion
Jan 30, 2023 (estimated)
Completion
Apr 2023 (estimated)
Last update
Dec 8, 2021

Study contacts

Reham A Ibrahim, MBBS
Contact
rehamabdalla@live.com
1006033730 ext. +20
Aya Y Badran, Lecturer
Contact
aya_badran@yahoo.com
1013244819 ext. +20
Sahar Ismaiel, Professor
study director · Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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