None listed
Conditions
Brief summary
Recently in countries that have vaccinated large volumes of their population, there have been many reports of women on social media and in other media describing changes in the menstrual cycle after receiving the Pfizer-BioNTech and Astra_Zeneca vaccines for COVID-19. The changes reported include alterations in the pattern of bleeding, postponement or advancement of the menstrual period, intermenstrual spotting, prolongation of bleeding and increased menstrual bleeding. Certain vaccines can cause a physiological trigger and increase cortisol levels in the body and thus can cause a temporary change in the menstrual cycle. A state of stress (conscription, war, significant life event) may directly impact on the menstrual cycle. Furthermore, the inflammatory response induced by a vaccine results in immune system products including cytokines and interleukins which also can have transient actions on the endometrium. In addition, the vaccine may affect menstrual symptoms such as dysmenorrhea, in other ways, via cytokines and other immune-mediated messengers. The study hypothesis is that the COVID 19 vaccine will cause no change to the pattern of bleeding (duration, volume, intensity, timing) and period related pain in reproductive age women both after a first dose and after two doses.
Interventions
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 participat
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.
Sponsors
Endometriosis research group, The Royal Women's hospital VIC
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed