Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine (MECOVAC-1)

Università degli Studi dell'Insubria

Status: Completed

Conditions: COVID-19; Menstrual Irregularity; Vaccine; Menopausal Bleeding

Treatments: Biological: Covid-19 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05083065

MECOVAC-1

Details and patient eligibility

About

Covid-19 vaccines offered a good opportunity to counteract the spread of Sars-Cov-2 infection among the general population, reducing significantly both morbidity and mortality.

Nevertheless, after the first and second doses of vaccination (regardless of the type of vaccine used) several women required gynaecological visits claiming menstrual Irregularities or abnormal uterine bleeding. Considering this anecdotal evidence, a questionnaire was designed to investigate systematically whether menstrual Irregularities or abnormal uterine bleeding occurred in a significant percentage of women undergoing first and second doses of covid-19 vaccination.

Enrollment: 369 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.

Exclusion criteria

• Women undergoing any kind of hormonal therapy, including combined oral contraceptives, oral/vaginal progestins, intrauterine devices, GnRH-analogues, aromatase inhibitors, hormonal replacement therapy in menopause;
• Surgical menopause (hysterectomy and/or bilateral oophorectomy);
• Breastfeeding.

Trial design

369 participants in 1 patient group

Women who underwent Covid-19 vaccination

Description:

This group includes women who underwent both the first or complete cycle of Covid-19 vaccination, regardless of the vaccine used.

Treatment:

Biological: Covid-19 vaccine