Evaluating the impact of HPV vaccine on menstrual cycles in women
Research for the Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age
This study is trying to see if getting the HPV vaccine affects menstrual cycles in women of childbearing age.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT05838157 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the association between HPV vaccination and changes in menstrual cycles among women of reproductive age. It focuses on identifying potential menstrual irregularities, such as amenorrhea and variations in cycle length, following vaccination with different HPV vaccine types. The study employs a self-control design, utilizing a self-designed questionnaire to collect menstrual data from participants who have received at least one dose of the HPV vaccine. The goal is to provide evidence regarding the safety of HPV vaccines in relation to menstrual health.
Who should consider this trial
Good fit: Ideal candidates for this study are women of reproductive age with previously regular menstrual cycles who have received at least one dose of an HPV vaccine.
Not a fit: Patients who are currently pregnant, breastfeeding, or have pre-existing menstrual disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could clarify the safety profile of HPV vaccines concerning menstrual health, potentially guiding future vaccination recommendations.
How similar studies have performed: While there have been retrospective studies on this topic, this prospective study design is relatively novel and aims to fill a gap in the existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Cancer Prevention Center,Sun Yat-sen University Cancer Cente — Guangzhou, Guangdong, China (Recruiting)
- Sun Yat-sen University Cancer Cente — Guangzhou, Guangdong, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Junjie Chen, Bachelor — Sun Yat-sen University
- Study coordinator: Juan Xiao, Master
- Email: xiaojuan@sysucc.org.cn
- Phone: 87345515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.