NCT04374422

Brief Summary

World Health Organization declared new SARS-CoV-2 infection a pandemic, and many states enacted strict, rules such as border closures, transportation restrictions and quarantine.Many studies in the literature have described the relationship between mass disasters and female sexual behavior, but none have investigated the effect of SARS-CoV-2 pandemic on women's sexual attitude. The aim of this study is therefore to evaluate the effect of SARS-CoV-2 pandemic on female sexual behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

2 days

First QC Date

April 29, 2020

Last Update Submit

May 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • FSFI (Female Sexual Function Index)SCORE difference

    the FSFI SCORE difference between pre and during pandemic

    1 year

Study Arms (2)

1

study group pre-pandemic time interval

Behavioral: fsfi survey

2

same population during pandemic

Behavioral: fsfi survey

Interventions

fsfi surveyBEHAVIORAL

sexual behavior Questionaire

12

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale sexual function
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From February 2018 to September 2019. For each participant, detailed medical history was obtained, including age, body mass index (BMI), education and income level, presence of comorbidities and the number of previous deliveries. Other details noted were menstrual status of patients, frequency of sexual intercourse and desire for fertility. All patients were asked to fill out the Female Sexual Function Index (FSFI) form. Patients' data were recorded in the electronic data system, prospectively. To identify the effect of SARS-CoV-2 pandemic on female sexual behavior, the investigators conducted an observational study to compare the frequency of sexual intercourse, desire for fertility, FSFI score, contraception type and presence of vaginal infection between pandemic era (March 11th and April 12th 2020) and 6-12 months prior to the pandemic.

You may qualify if:

  • married
  • above 18 yo
  • premenopausal status

You may not qualify if:

  • urinary incontinence
  • history of gynecologic operation
  • malignancy
  • psychiatric or neurologic disease diagnosis
  • being infected by HBV HCV or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, 34104, Turkey (Türkiye)

Location

Related Publications (2)

  • Liao X, Wang B, Kang Y. Novel coronavirus infection during the 2019-2020 epidemic: preparing intensive care units-the experience in Sichuan Province, China. Intensive Care Med. 2020 Feb;46(2):357-360. doi: 10.1007/s00134-020-05954-2. Epub 2020 Feb 5. No abstract available.

  • Liu S, Han J, Xiao D, Ma C, Chen B. A report on the reproductive health of women after the massive 2008 Wenchuan earthquake. Int J Gynaecol Obstet. 2010 Feb;108(2):161-4. doi: 10.1016/j.ijgo.2009.08.030. Epub 2009 Nov 4.

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 5, 2020

Study Start

April 10, 2020

Primary Completion

April 12, 2020

Study Completion

April 12, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations