FERTILITY FUNCTIONS IN 4VHPV VACCINATED ARMENIAN COHORT.

Introduction: Despite being highly preventable, cervical cancer (CC) is the eighth most prevalent form of female cancer in Armenia and the second most common malignancy among those aged 15 to 44. In Armenia, there is an age-standardized incidence of 7.8 per 100,000 females, and an age-standardized mortality of 4.6 per 100,000 females. Globally, the CC is the 4th most common cancer among women. Its incidence was 604,127 new cases and 341,831 deaths in 2020. We conducted a retrospective, observational cohort study using clinical data to verify the influence of HPV vaccine (Gardasil, Merck&CO) on fertility function in women, vaccinated in RA since 2017 year in the limits of anti-HPV vaccination Program (included in National Vaccination Calendar).

Materials and methods: For the study, we analyzed data received from Armenian-American Wellness Center (Yerevan, Armenia). 98 female volunteers vaccinated with the 4vHPV who attended AAWC and were examined for reproductive function. The subjects were divided into 3 age groups - 1st group - 15 years -24 years 11 months, 2nd group - 25 years -34 years 11 months, 3rd group - 35 -40 years. Each control group was composed of randomly selected 30 healthy women in age identical to the main group who applied AAWC for regular checkup in the same time frame and have never been exposed to anti HPV vaccine.

Results: The current research is aimed to reveal any negative impact of 4vHPV vaccine on fertility indicators in Armenian cohort. The performed comparative statistical analysis of the assessed indicators has revealed the ORs<1 for POI, late fertilization disorders of menstrual cycle and anovulation prevalence indicators. The chance of investigated disorders' development in 4vHPV vaccine exposed cohort did not exaggerate that in non-exposed sample cohort. The significant difference was not observed in Anti-Mullerian Hormone, FSH basal levels, as well as in mean ovarian volume and number of antral follicles indicators between clinical and respective control groups (p<.05).

Conclusion: The data obtained make us to conclude about absence of any negative impact of 4vHPV vaccine on fertility function indicators in 4vHPV vaccinated cohort in RA. The study results contribute to perception of the 4vHPV vaccine safety concept, what in its turn can trigger increase of vaccination coverage leading to CC control efficiency.