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Trial registered on ANZCTR


Registration number
ACTRN12621001317886p
Ethics application status
Submitted, not yet approved
Date submitted
19/09/2021
Date registered
28/09/2021
Date last updated
28/09/2021
Date data sharing statement initially provided
28/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the vaccine for COVID-19 on menstrual cycle symptoms in healthy women
Scientific title
The effect of the vaccine for COVID-19 on menstrual cycle symptoms in healthy women
Secondary ID [1] 305349 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual symptoms 323673 0
COVID 19 vaccine 323674 0
Condition category
Condition code
Reproductive Health and Childbirth 321213 321213 0 0
Menstruation and menopause
Inflammatory and Immune System 321231 321231 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Post COVID-19 vaccine effect on menstrual cycle symptoms.
The administration of the COVID-19 vaccine is not a component of this study.
Participants will be recruited in vaccination hubs when they come to receive their first COVID 19 vaccine, and will receive their subsequent vaccine as recommended by the Department of Health and Human Services (DHHS) for each of the different vaccines.
We will recruit fertility aged people 18-45 years old.
The participants will give their consent for participation and fill the initial questionnaire through a QR link online.
The questionnaire will ask about their medical health, obstetric and Gynae history, menstrual bleeding pattern, period pain, stress and anxiety in the past 3 months and COVID vaccination status. A similar subsequent questionnaire will be send to each participant by email at 3, 6, 9 and again 12 months after receiving the first vaccine. Filling each if the questionnaires should take 10-15 min.
Each participant will be the control of herself.
Intervention code [1] 321755 0
Not applicable
Comparator / control treatment
Control- Each participant will be the control of herself.
Control group
Historical

Outcomes
Primary outcome [1] 328998 0
Changes to the menstrual cycle patterns in women of reproductive age following the vaccine for COVID-19 will be assessed as a composite of the following: the regularity, length and volume of menstrual bleeding as well as intensity of period pain (Dysmenorrhoea).
These will be compared for each patient at her 3,6,9 and 12 months data questionnaire to her pre vaccine data taken from her initial questionnaire.
Menstrual disturbance (a general term for any of the above changes), includes menses six or more days earlier or later than expected, increased or decreased length by 2 or more days, intermenstrual bleeding, and increased amount of bleeding on a 4 point bleeding scale.
Dysmenorrhoea changes - the appearance of new onset or change in dysmenorrhea severity of 2+ points on an 11 point numeric pain scale after vaccination.
The primary outcome is to prove/disprove any menstrual changes following the vaccine. In the secondary outcomes we will study separately each of the potential changes.
The anxiety assessment questions were taken from GAD-7, a validated questionnaire.
The stress assessment questions were taken from "The Perceived Stress Scale", a validated questionnaire.
The bleeding volume assessment and pain score NRS are both validated tools.
The rest of the questions in the questionnaires are specific to this study.


Timepoint [1] 328998 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine
Secondary outcome [1] 401118 0
To compare the change in bleeding volume for each participant before and after the vaccination.
The participants will report their bleeding volume through a validated "pictorial blood loss assessment table" in the baseline questionnaire (pre vaccination) and again at 3, 6, 9, and 12 months post first vaccination.
The amount of bleeding will be assessed on a 4 point bleeding scale.
Timepoint [1] 401118 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine
Secondary outcome [2] 401119 0
To compare the change in bleeding length for each participant before and after the vaccination.
The participants will report their bleeding length by study-specific questions, in the baseline questionnaire (pre vaccination) and again at 3, 6, 9, and 12 months post first vaccination.
The bleeding length will be regarded as different if it is increased or decreased by 2 or more days.
Timepoint [2] 401119 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine
Secondary outcome [3] 401120 0
To compare the change in bleeding regularity for each participant before and after the vaccination.
The participants will report their bleeding patterns by study-specific questions, in the baseline questionnaire (pre vaccination) and again at 3, 6, 9, and 12 months post first vaccination.
Menstrual disturbance includes menses six or more days earlier or later than expected or new onset of intermenstrual bleeding.
Timepoint [3] 401120 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine
Secondary outcome [4] 401121 0
To compare the change in dysmenorrhoea NRS score for each participant before and after the vaccination.
Timepoint [4] 401121 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine
Secondary outcome [5] 401122 0
To asses the duration of the bleeding volume changes after the COVID 19 vaccination.
Bleeding volume changes will be assessed by study-specific questionnaire. This outcome is only to assess how long these changes will continue for. This will be asked at each repeated questionnaire.
Timepoint [5] 401122 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine
Secondary outcome [6] 401183 0
To asses the duration of the bleeding length changes after the COVID 19 vaccination.
Timepoint [6] 401183 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine
Secondary outcome [7] 401184 0
To asses the duration of the bleeding regularity changes after the COVID 19 vaccination.
Bleeding regularity changes will be assessed by study-specific questionnaire. This outcome is only to assess how long these changes will continue for. This will be asked at each repeated questionnaire.
Timepoint [7] 401184 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine
Secondary outcome [8] 401185 0
To asses the duration of the dysmenorrhoea changes after the COVID 19 vaccination.
Dysmenorrhoea changes will be assessed by study-specific questionnaire. This outcome is only to assess how long these changes will continue for. This will be asked at each repeated questionnaire.
Timepoint [8] 401185 0
Baseline - at the time of first vaccination ( data from 3 months prior to receiving the vaccine), and 3, 6, 9 and 12 months after receiving the first vaccine

Eligibility
Key inclusion criteria
• Premenopausal individuals who have had at least one period in the past
• Currently having periods or
• Currently not having periods due to other reasons eg. using hormonal contraceptives, using gender affirming hormones
• Have not yet been vaccinated but are planning on having the COVID-19 vaccine soon or have received their first dose on day of recruitment
• Healthy people (without blood disorders or known hematological diseases)
• Aged 18-45
• Interested in participating in the study and consent to regular monitoring of their menstruation.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• People who are already vaccinated against COVID
• People who never had periods
• People who are post menopausal, pregnant, breastfeeding or who plan pregnancy in the next 12 months.
• People who have had a hysterectomy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The results will be summarized using descriptive statistics and processed using SPSS software. 95% confidence intervals will be calculated for any estimated proportions. Comparisons between proportions will be made using logistic regression. All tests will be two-tailed, and p-value of 0.05 or less and will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
Date of last participant enrolment
Anticipated
10/10/2022
Actual
Date of last data collection
Anticipated
16/10/2023
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309719 0
Other Collaborative groups
Name [1] 309719 0
Endometriosis research group, The Royal Women's hospital VIC
Country [1] 309719 0
Australia
Funding source category [2] 309720 0
Other Collaborative groups
Name [2] 309720 0
Endometriosis research group, Melbourne Uni, Obs&Gynae research lab
Country [2] 309720 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Endometriosis research group, The Royal Women's hospital VIC
Address
The Royal Women's Hospital
20 Flemington Rd.
Parkville 3052, VIC
Country
Australia
Secondary sponsor category [1] 310740 0
Other Collaborative groups
Name [1] 310740 0
Endometriosis research group, Melbourne Uni, Obs&Gynae research lab
Address [1] 310740 0
The Royal Women's Hospital
Level 7
20 Flemington Rd.
Parkville 3052, VIC
Country [1] 310740 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309482 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 309482 0
Ethics committee country [1] 309482 0
Australia
Date submitted for ethics approval [1] 309482 0
30/08/2021
Approval date [1] 309482 0
Ethics approval number [1] 309482 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114298 0
Dr Michal Amir
Address 114298 0
The Royal Women's Hospital
20 Flemington Rd.
Parkville 3052, VIC
Country 114298 0
Australia
Phone 114298 0
+61403274870
Fax 114298 0
Email 114298 0
dr.amirmichal@gmail.com
Contact person for public queries
Name 114299 0
Michal Amir
Address 114299 0
The Royal Women's Hospital
20 Flemington Rd.
Parkville 3052, VIC
Country 114299 0
Australia
Phone 114299 0
+61403274870
Fax 114299 0
Email 114299 0
michal.amir@thewomens.org.au
Contact person for scientific queries
Name 114300 0
Michal Amir
Address 114300 0
The Royal Women's Hospital
20 Flemington Rd.
Parkville 3052, VIC
Country 114300 0
Australia
Phone 114300 0
+61403274870
Fax 114300 0
Email 114300 0
dr.amirmichal@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.