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

• ClinicalTrials.gov Identifier: NCT05083065
• Recruitment Status: Completed
• First Posted: October 19, 2021
• Last Update Posted: November 2, 2022
• Sponsor: Università degli Studi dell'Insubria
• Information provided by (Responsible Party): Antonio Simone Laganà, Università degli Studi dell'Insubria

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
COVID-19; Vaccine; Menstrual Irregularity; Menopausal Bleeding	Biological: Covid-19 vaccine

Study Design

• Study Type: Observational
• Actual Enrollment: 369 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
• Actual Study Start Date: September 10, 2021
• Actual Primary Completion Date: October 10, 2021
• Actual Study Completion Date: December 30, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Women who underwent Covid-19 vaccination; This group includes women who underwent both the first or complete cycle of Covid-19 vaccination, regardless of the vaccine used.	Biological: Covid-19 vaccine; First dose or complete cycle of Comirnaty (Pfizer/BioNTech) vaccine; First dose or complete cycle of Spikevax (Moderna) vaccine; First dose or complete cycle of AstraZeneca/Vaxzevria vaccine; Complete cycle of vaccination using one type of vaccine for the first dose and a different type for the second dose; Janssen (Johnson & Johnson) vaccine (single dose)

Outcome Measures

Primary Outcome Measures :

1. Frequency of the menstrual cycle [ Time Frame: 30 days after the administration of the first and second doses of vaccine ]
   In women of reproductive age, any frequency shorter than 25 days or longer than 36 days will be defined as abnormal
2. Quantity of the menstrual cycle [ Time Frame: 30 days after the administration of the first and second doses of vaccine ]
   In women of reproductive age, any quantity less than 30 ml or more than 80 ml will be defined as abnormal
3. Duration of the menstrual cycle [ Time Frame: 30 days after the administration of the first and second doses of vaccine ]
   In women of reproductive age, any duration shorter than 3 days or longer than 7 days will be defined as abnormal

Secondary Outcome Measures :

1. Post-menopausal bleeding [ Time Frame: 30 days after the administration of the first and second doses of vaccine ]
   Any bleeding occurred in post-menopausal women

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Locations

Italy

University of Insubria

Varese, Italy

Sponsors and Collaborators

Università degli Studi dell'Insubria

Investigators

• Principal Investigator: Antonio Simone Laganà, M.D., Ph.D.; Università degli Studi dell'Insubria

More Information

• Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
• ClinicalTrials.gov Identifier: NCT05083065
• Other Study ID Numbers: MECOVAC-1
• First Posted: October 19, 2021
• Last Update Posted: November 2, 2022
• Last Verified: October 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:

Covid-19 vaccine; Menstrual Irregularity; Menopausal Bleeding

Additional relevant MeSH terms:

COVID-19; Uterine Hemorrhage; Hemorrhage; Menstruation Disturbances; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases