Premature Ovarian Failure Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Cancer Prevention Center,Sun Yat-sen University Cancer Cente | Guangzhou | Guangdong |
China | Sun Yat-sen University Cancer Cente | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
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.1 — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. eColl — View Citation
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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. 202 — View Citation
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 Evid — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Premature ovarian failure (POF) signals | 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) |
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