NCT05838157

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 4, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

April 3, 2023

Last Update Submit

June 8, 2023

Conditions

Menstrual DisorderPremature Ovarian Failure

Keywords

HPV vaccinemenstrual cyclemenstrual disorderpremature ovarian insufficiency

Outcome Measures

Primary Outcomes (3)

  • Frequency of the menstrual cycle

    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

    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

    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 Outcomes (1)

  • Premature ovarian failure (POF) signals

    3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)

Study Arms (1)

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)

Interventions

prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV)BIOLOGICAL

at least one dose of prophylactic HPV vaccine including bivalent HPV (2vHPV)， quadrivalent HPV vaccine (4vHPV)，9-valent HPV vaccine (9vHPV)

Girls and women aged 16 to 40 years who receiving at least one dose of HPV vaccination

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer Prevention Center,Sun Yat-sen University Cancer Cente

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-sen University Cancer Cente

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Related Publications (8)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338RESULT

  • de Sanjose S, Delany-Moretlwe S. HPV vaccines can be the hallmark of cancer prevention. Lancet. 2019 Aug 10;394(10197):450-451. doi: 10.1016/S0140-6736(19)30549-5. Epub 2019 Jun 26. No abstract available.

    PMID: 31255298RESULT

  • Gong L, Ji HH, Tang XW, Pan LY, Chen X, Jia YT. Human papillomavirus vaccine-associated premature ovarian insufficiency and related adverse events: data mining of Vaccine Adverse Event Reporting System. Sci Rep. 2020 Jul 1;10(1):10762. doi: 10.1038/s41598-020-67668-1.

    PMID: 32612121RESULT

  • Hviid A, Myrup Thiesson E. Association Between Human Papillomavirus Vaccination and Primary Ovarian Insufficiency in a Nationwide Cohort. JAMA Netw Open. 2021 Aug 2;4(8):e2120391. doi: 10.1001/jamanetworkopen.2021.20391.

    PMID: 34436612RESULT

  • Colafrancesco S, Perricone C, Tomljenovic L, Shoenfeld Y. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013 Oct;70(4):309-16. doi: 10.1111/aji.12151. Epub 2013 Jul 31.

    PMID: 23902317RESULT

  • Tatang C, Arredondo Bisono T, Bergamasco A, Salvo F, Costa Clemens SA, Moride Y. Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System. Drugs Real World Outcomes. 2022 Mar;9(1):79-90. doi: 10.1007/s40801-021-00271-6. Epub 2021 Sep 12.

    PMID: 34510402RESULT

  • Torella M, Marrapodi MM, Ronsini C, Ruffolo AF, Braga A, Frigerio M, Amabile E, Vastarella MG, Rossi F, Riemma G. Risk of Premature Ovarian Insufficiency after Human Papilloma Virus Vaccination: A PRISMA Systematic Review and Meta-Analysis of Current Evidence. Vaccines (Basel). 2023 Jan 9;11(1):140. doi: 10.3390/vaccines11010140.

    PMID: 36679985RESULT

  • Little DT, Ward HR. Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination: A Case Series Seen in General Practice. J Investig Med High Impact Case Rep. 2014 Oct 28;2(4):2324709614556129. doi: 10.1177/2324709614556129. eCollection 2014 Oct-Dec.

    PMID: 26425627RESULT

MeSH Terms

Conditions

Menstruation DisturbancesPrimary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Juan Xiao, Master

    Sun Yat-sen University

    STUDY DIRECTOR

  • Chuanbo Xie, PhD

    Sun Yat-sen University

    STUDY DIRECTOR

  • Junjie Chen, Bachelor

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Huiping Ye, Bachelor

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Xiao, Master

CONTACT

87345515xiaojuan@sysucc.org.cn

Chuanbo Xie, PhD

CONTACT

87345505xiecb@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

April 3, 2023

First Posted

May 1, 2023

Study Start

May 4, 2023

Primary Completion

May 31, 2024

Study Completion

December 31, 2024

Last Updated

June 9, 2023

Record last verified: 2023-06

Locations

CN(2)