NCT05688995

Brief Summary

The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle

Trial Health

87
On Track

Trial Health Score

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

Enrollment
617

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

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

September 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 17, 2023

Last Update Submit

January 17, 2023

Conditions

Menstrual Irregularity

Outcome Measures

Primary Outcomes (1)

  • significant changes in the menstrual cycle after vaccination

    changes that involve bleeding amount or pain

    6 months

Interventions

Naser Al-HusbanBIOLOGICAL

COVID-19 vaccines

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with menstrual cycle
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Our study included 617 Menstruating females. 74.55% of participants were of the age group between 20-35 years. 59.64% had normal BMI (18.5-24.9 Kg/m2), while 11.99% were underweight (BMI less than 18.5 Kg/m2), 19.77% were overweight (BMI\>24.9 Kg/m2 but less than 30 Kg/m2), and 8.59% were obese (BMI more than 30 Kg/m2). Largest BMI was 39.79 Kg/m2. Most of participants were single ladies (79.25%). 82.01% were nulliparous. 17.83% were multiparous, including 1.62% ladies that had 5 or more children (grand multiparous).

You may qualify if:

  • years and older
  • less than 40 years
  • healthy women
  • received covid-19 vaccine

You may not qualify if:

  • women who did not receive the vaccine
  • those living outside Jordan (those cannot fill the form) and during analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University Hospital

Amman, 11941, Jordan

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Naser U Al-Husban

    The University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 18, 2023

Study Start

September 30, 2021

Primary Completion

December 30, 2021

Study Completion

January 1, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

JO(1)