Prevalence of HPV Transmission During Medically Assisted Procreation Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 915
- 试验地点
- 10
- 主要终点
- Presence of HPV DNA on a swab sampled in the throat of newborns from one or two parents detected positive for HPV in semen and/or cervicovaginal scrape
研究概览
简要总结
Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. At the present time, no recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP) procedures. The main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the correlation between HPV and male infertility and (4) the correlation between HPV and success rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV vaccination policy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Age under 40 for women
- •Signed informed consent by both members of the couple
- •Medical indication of MAP by AI (artificial insemination), IVF(in vitro fertilization) or ICSI (intracytoplasmic sperm injection) method
- •Well understanding of information letter
排除标准
- •Age over 40 for women
- •Informed consent form not signed by one or both partners
- •Co-infection of one of the partners or both by HIV (human immunodeficiency virus) , HBV (hepatitis B virus) and/or HCV (hepatitis C virus)
- •IVF by only frozen embryo transfer at the time of inclusion
- •Severe oligospermia in male partner (<500 000 sperm cells)
研究组 & 干预措施
Population of couples candidate for MAP program
MAP = medically assisted procreation
干预措施: Systematic HPV DNA assay in semen and cervicovaginal scrape (Other)
Population of couples candidate for MAP program
MAP = medically assisted procreation
干预措施: Systematic HPV DNA cervicovaginal scrape (Other)
Population of couples candidate for MAP program
MAP = medically assisted procreation
干预措施: systematic HPV Status in newborns in case of pregnancy (Other)
结局指标
主要结局
Presence of HPV DNA on a swab sampled in the throat of newborns from one or two parents detected positive for HPV in semen and/or cervicovaginal scrape
时间窗: at birth
次要结局
- Quantitative and qualitative parameters of MAP procedures: fertilization rate, number of ovocytes, number of embryos…(At the time of enrollment, during MAP procedures and at birth (in case of))
- Genotype of HPV(At the time of enrollment, during MAP procedures and at birth (in case of))
- Presence of HPV DNA in ovocytes samples and in embryo culture media(At the time of enrollment, during MAP procedures and at birth (in case of))
- Presence of HPV DNA in seminal fractions: seminal plasma, sperm cells dedicated to MAP(At the time of enrollment, during MAP procedures and at birth (in case of))
- Quantitative et qualitative parameters of spermogram analysis: volume of the ejaculate, number, mobility and morphology of sperm cells according to WHO criteria)(At the time of enrollment, during MAP procedures and at birth (in case of))