COVID-19 vaccination and menstrual cycle characteristics: A prospective cohort study

Wesselink, Amelia K.; Lovett, Sharonda M.; Weinberg, Janice; Geller, Ruth J.; Wang, Tanran R.; Regan, Annette K.; Willis, Mary D.; Perkins, Rebecca B.; Yland, Jennifer J; Koenig, Martha R.; Rothman, Kenneth J.; Hatch, Elizabeth E.; Wise, Lauren A.

doi:10.1016/j.vaccine.2023.06.012

Cited by 15 publications

(13 citation statements)

References 47 publications

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“…Several large-scale app-based studies have also shown that the primary series of COVID-19 mRNA vaccinations cause slight transient menstrual prolongation. 8,9,11,16 Furthermore, participants who received the primary series in the same cycle also had a greater degree of prolongation than those who received them separately, 8,9 and perimenopausal age has been identified as a risk factor for such prolongation. 26 Moreover, in two previous studies, vaccination during the follicular phase caused longer menstrual prolongation than during the luteal phase, similar to our findings.…”

Section: Discussionmentioning

confidence: 99%

“…[8][9][10][11][12][13][14][15][16] Although most descriptive studies are based on self-reported data, several studies using applications (apps) with menstrual cycle data logs have quantitatively analyzed the effect of the primary-series (first and second) shots, revealing slight prolongation in the first menstrual cycle after vaccination, which resolved in subsequent cycles. 8,9,11,13,16 However, these larger studies have focused only on the primary series, and little is known about the effect of the booster shot. 17,18 Moreover, menstrual cyclicity varies among ethnicities, 19 and there have been few reports in Asian women.…”

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confidence: 99%

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Prolongation of the Menstrual Cycle After Receipt of the Primary Series and Booster Doses of mRNA Coronavirus Disease 2019 (COVID-19) Vaccination

Hosoya,

Piedvache,

Nakamura

et al. 2023

Obstetrics &Amp; Gynecology

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OBJECTIVE: To quantitatively evaluate the effect of a booster vaccination dose against coronavirus disease 2019 (COVID-19) on menstrual cycle in a large-scale retrospective cohort study using a menstrual cycle tracking smartphone application (app). METHODS: Prospectively or retrospectively recorded data, including the start and finish dates of menstrual cycles, were collected with the app. Detailed data on vaccinations, side effects, and participants' characteristics were retrospectively collected from a questionnaire on the app. For each COVID-19 vaccination shot (first, second, and third), within-individual changes in menstrual cycle length up to the fourth postvaccination cycle were evaluated. RESULTS: Among the 7,376 and 6,873 participants who had the first and second COVID-19 vaccine doses in different menstrual cycles, respectively, menstrual cycles immediately after the vaccination (first postvaccination cycles) were an average of 0.22 days (95% CI, 0.06–0.39) and 0.37 days (95% CI, 0.20–0.54) longer than the prevaccination cycle. In contrast, among the 1,672 participants who received the first and second doses in the same cycle, the first postvaccination cycle was an average of 4.21 days (95% CI, 3.69–4.72) longer. The second to fourth postvaccination cycles returned to the level of the prevaccination cycle. However, among the 4,768 participants who had the third COVID-19 vaccine dose, the menstrual cycle immediately after the vaccination was an average of 1.20 days (95% CI, 1.00–1.40) longer, with prolongation of cycles of 0.27 days (95% CI, 0.10–0.44) to 0.41 days (95% CI, 0.22–0.59) persisting from the second to the fourth postvaccination cycle. CONCLUSION: The booster shot against COVID-19 may have a greater and longer-lasting effect on menstrual cycles than the primary-series shots. Although the effect size was small, evidence on the side effects of immunization on menstruation should be accumulated.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Prolongation of the Menstrual Cycle After Receipt of the Primary Series and Booster Doses of mRNA Coronavirus Disease 2019 (COVID-19) Vaccination

Hosoya,

Piedvache,

Nakamura

et al. 2023

Obstetrics &Amp; Gynecology

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“…We also note contraceptives are not the only drug, device, or biologic to impact the menstrual cycle, yet such data are not routinely collected during clinical trials or during standard toxicology and pharmacodynamics studies, as other organ functions and vital signs are. The lack of these data was recently highlighted with the initial introduction of COVID vaccinations when vaccinated people who could or did menstruate experienced unanticipated bleeding changes [38][39][40][41][42]. We hope our work can be a guide and an invitation to develop recommendations for if, when, and how to measures changes to the menstrual cycle in more types of clinical trials and related research.…”

Section: Future Implicationsmentioning

confidence: 96%

Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials

Mackenzie,

Chung,

Hoppes

et al. 2024

Preprint

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ObjectiveWe sought to develop consensus recommendations for improved measurement of contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials to build upon previous standardization efforts.Study DesignWe undertook a virtual consensus-building process using a modified Delphi approach, incorporating aspects of Nominal Group Technique and the Jandhyala method. The process consisted of four half-day meetings, developing recommendations within five topical working groups, a series of consensus questionnaires to assess recommendation agreement on a 4-point Likert-like scale, and opportunities for input and feedback throughout the process. Recommendations required at least 75% consensus to be included.ResultsOur interdisciplinary group—from 26 organizations and 13 countries in five global regions across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies— developed 44 consensus recommendations. These included recommendations on standardization, patient-reported outcome measure development aligned with current regulatory guidance, trial design, protocol development, participant recruitment, data collection, data analysis, and areas for exploratory research. Seven recommendations were deemed a priority by over 85% of our group.ConclusionUsing a formal consensus-building process, we reached high levels of agreement around recommendations for more standardized and patient-centered measurement of CIMCs in contraceptive clinical trials, now and in the future.Implications statementConsensus recommendations on measuring bleeding changes and related outcomes in contraceptive clinical trials can improve reporting of standardized, patient-centered outcomes in future product labeling. These improvements can enable providers to offer more relevant counseling on contraceptives and permit greater comparability and data synthesis across trials to inform clinical guidance.

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“…The importance of data on menstrual changes in the clinical trial context was recently highlighted during the introduction of COVID vaccinations. Because vaccine trials did not collect data on any impact to the menstrual cycle or menopausal uterine bleeding, there were concerns among vaccinated people who menstruate when they experienced these changes, which can erode trust in clinical research and public health interventions [24][25][26][27][28].…”

Section: Clinical Trial Contextmentioning

confidence: 99%

Measurement of changes to the menstrual cycle: A transdisciplinary systematic review evaluating measure quality and utility for clinical trials

Mackenzie,

Chung,

Hoppes

et al. 2024

Preprint

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Despite the importance of menstruation and the menstrual cycle to health, human rights, and sociocultural and economic wellbeing, the study of menstrual health suffers from a lack of funding, and research remains fractured across many disciplines. We sought to systematically review approaches to measure four aspects of changes to the menstrual cycle—bleeding, blood, pain, and perceptions— caused by any source and used in any field. We searched MEDLINE, Embase, and four instrument databases and included peer-reviewed articles published between 2006 and 2023 that reported on the development or validation of instruments assessing menstrual changes using quantitative or mixed-methods methodology. We evaluated instruments on measure quality and utility for clinical trials. From a total of 8,490 articles, 8,316 were excluded (i.e., 376 duplicates, 7,704 during title/abstract screening, and 236 during full text review), yielding 94 instruments from 174 included articles. Almost half of articles were from the United States or United Kingdom and over half of instruments were only in English, Spanish, French, or Portuguese. Most instruments measured bleeding, pain, or perceptions, but few assessed blood. Nearly 60% of instruments were developed for populations with menstrual or gynecologic disorders or symptoms. Most instruments had fair or good measure quality and/or clinical trial utility; however, most instruments lacked evidence on responsiveness, question sensitivity and/or transferability, and only three instruments had good scores of both quality and utility. Although we took a novel, broad, and transdisciplinary approach, our systematic review found important gaps in the literature and instrument landscape and a need to examine the menstrual cycle in a more comprehensive, inclusive, and standardized way. Our findings can inform the development of new or modified instruments, which—if used across the many fields that study menstrual health—can contribute to a more systemic and holistic understanding of menstruation and the menstrual cycle.

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COVID-19 vaccination and menstrual cycle characteristics: A prospective cohort study

Cited by 15 publications

References 47 publications

Prolongation of the Menstrual Cycle After Receipt of the Primary Series and Booster Doses of mRNA Coronavirus Disease 2019 (COVID-19) Vaccination

Prolongation of the Menstrual Cycle After Receipt of the Primary Series and Booster Doses of mRNA Coronavirus Disease 2019 (COVID-19) Vaccination

Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials

Measurement of changes to the menstrual cycle: A transdisciplinary systematic review evaluating measure quality and utility for clinical trials

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