The Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age

June 8, 2023 updated by: Xiao Juan, Sun Yat-sen University

Research for the Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age

Cervical cancer is one of the most common cancer in women, making it the fourth largest cause of female cancer mortality worldwide. High-risk HPV types (hrHPV) continuous infection is the main cause of the premalignant and malignant lesions of the cervix. The most effective primary prevention of cervical cancer is administration HPV vaccines. There are three prophylactic HPV vaccines including bivalent HPV (2vHPV)， quadrivalent HPV vaccine (4vHPV)，9-valent HPV vaccine (9vHPV) currently. With the widespread of HPV vaccination， the cases related to abnormal menstrual cycle or menstrual irregularities has gradually increased in the Vaccine Adverse Event Reporting System, also the number of reports and studies were increasing. We designed this study to evaluate the statistical association of HPV vaccine and changes in menstrual cycle or menstrual irregularities、amenorrhea. And detect the signal of premature ovarian insufficiency (POI) and related events of three HPV vaccines, and to provide evidence for the safety of HPV vaccines based on the data mining and signal detection method. The research data was obtained from prospective self- developed questionnaire. Before-after study was applied in this study, investigators collect the menstrual cycle data of subjects by the questionnaire and qualitatively interview were taken. The control group is before vaccination, HPV vaccination is Intervention group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

High-risk HPV types (hrHPV) continuous infection is the main cause of the premalignant and malignant lesions of the cervix. The most effective primary prevention of cervical cancer is administration HPV vaccines. There are three prophylactic HPV vaccines including bivalent HPV (2vHPV)， quadrivalent HPV vaccine (4vHPV)，9-valent HPV vaccine (9vHPV) currently. With the widespread of HPV vaccination， the cases related to abnormal menstrual cycle or menstrual irregularities has gradually increased in the Vaccine Adverse Event Reporting System, also the number of reports and studies were increasing. Whereas all of the studies are retrospective and the data from passive surveillance system, meanwhile, HPV vaccines has been available in Chinese mainland less than 7 years. Especially, 9vHPV applicable range was broadened to 45 years shortly before. There are rarely prospective researches focus on the connection between HPV vaccines and menstrual disorder. We designed this prospective study to observe and evaluate the statistical association of HPV vaccine and menstrual disorder such as menstrual irregularities、amenorrhea、 hypomenorrhea or hypermenorrhea in Chinese women. And detect the signal of premature ovarian insufficiency (POI) and related events of three HPV vaccines, and to provide evidence for the safety of HPV vaccines based on the data mining and signal detection method.

The study design used self-control, We using a self-designed questionnaire collect the menstruation data of girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during May 10th 2023 to April 30th 2023. The self-designed questionnaire contains three parts. First part includes personal basic information such as age, profession, education Level, marital or childbearing status etc. Part two there are containing health status, menstruation conditions (include menstrual cycle, menstrual period, menstrual blood volume and dysmenorrhea etc). Part three collects menstruation conditions by qualitatively interview , covers each menstrual cycle after the first dose of HPV vaccination until 3 months after the third dose .

To analyze the data, R studio statistical software was used. The general measurement data were analyzed by paired sample T test, p=0.05. Bayesian trusted Propagation neural network (BCPNN) and multi-item gamma Poisson contractor (MGPS) were used to detect the signals of POI related events and to conduct empirical Bayes data mining among ours database.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Cancer Prevention Center,Sun Yat-sen University Cancer Cente
        • Contact:
        • Principal Investigator:
          • XIAO Juan, Master
        • Sub-Investigator:
          • XIE Chuanbo, PhD
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Sun yat-sen university cancer cente
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during April 10th 2023 to April 30th 2023.

Description

Inclusion Criteria:

  • Previous menstrual cycles were regular and normal
  • At least one vaccination of HPV vaccine

Exclusion Criteria:

  • Pregnancy
  • Breast-feeding
  • Record of abnormal results of HPV test/ cervical cytology/ gynecological ultrasonography
  • Record of medications related to menstruation
  • Diseases contribute to menstrual irregularities、amenorrhea such as severe anemia/ coagulation disorders/ thyroid dysfunction etc.
  • Participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Girls and women aged 16 to 40 years who receiving at least one dose of HPV vaccination
Girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during April 10th 2023 to April 30th 2023.
Biological: prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV)
at least one dose of prophylactic HPV vaccine including bivalent HPV (2vHPV)， quadrivalent HPV vaccine (4vHPV)，9-valent HPV vaccine (9vHPV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of the menstrual cycle
Time Frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
In 16~40 years old women , any frequency shorter than 21 days or longer than 36 days will be defined as abnormal
3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
Duration of the menstrual cycle
Time Frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
In 16~40 years old women , any duration shorter than 3 days or longer than 7 days will be defined as abnormal
3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
Quantity of the menstrual cycle
Time Frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
In 16~40 years old women , any quantity less than 30 ml or more than 80 ml will be defined as abnormal
3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature ovarian failure (POF) signals
Time Frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
From the first dose of the vaccine, Blood biochemical detection used to measure the levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), testosterone (T) and prolactin (PRL). And Ultrasonography is used to detected changes in the endometrium after each vaccination.
3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Juan Xiao, Master, Sun Yat-sen University
  • Study Director: Chuanbo Xie, PhD, Sun Yat-sen University
  • Principal Investigator: Junjie Chen, Bachelor, Sun Yat-sen University
  • Principal Investigator: Huiping Ye, Bachelor, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022111615154477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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