Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05838157
Study type Observational
Source Sun Yat-sen University
Contact Juan Xiao, Master
Phone 87345515
Email xiaojuan@sysucc.org.cn
Status Recruiting
Phase
Start date May 4, 2023
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Unknown status NCT01853501 - Effects of ADSC Therapy in Women With POF Phase 4
Completed NCT00417066 - Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders Phase 4
Active, not recruiting NCT04675970 - Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy
Recruiting NCT03480412 - Second Step Protocol in Poor Ovarian Responder (POR)
Completed NCT02644447 - Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF Phase 1/Phase 2
Completed NCT03840824 - Blood Spot Self-administered Test and Assay
Recruiting NCT00119925 - 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists" N/A
Recruiting NCT06117982 - The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency Phase 2
Suspended NCT03816852 - The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency Phase 2
Not yet recruiting NCT04390308 - Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
Completed NCT02783937 - Filgrastim for Premature Ovarian Insufficiency Phase 4
Completed NCT00295087 - X-Chromosome Inactivation Status and Premature Ovarian Failure N/A
Completed NCT00429494 - GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients Phase 2
Not yet recruiting NCT05522634 - A Clinical Study of Chinese Herbal Compound TJAOA101 in the Treatment of Premature Ovarian Insufficiency Early Phase 1
Withdrawn NCT01129947 - The Use of DHEA in Women With Premature Ovarian Failure Phase 0
Completed NCT00001275 - Ovarian Follicle Function in Patients With Primary Ovarian Failure N/A
Not yet recruiting NCT04306185 - Ovarian Fragmentation Study (Crespo Medical Team) N/A
Recruiting NCT02062931 - Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure Phase 1/Phase 2
Completed NCT02151890 - Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure Phase 1/Phase 2
Completed NCT02372474 - "It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure Phase 1/Phase 2