Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 4
- 主要终点
- HPV test for participating women (cervicovaginal sample): positive/negative
研究概览
简要总结
The main objective of this study is to investigate the association between the presence of HPV infection in one or both members of infertile/sub-infertile couples and the outcome of pregnancies obtained by assisted reproduction.
The success of assisted medical procreation is defined as achieving a pregnancy resulting in the birth of a living, viable child.
详细描述
The secondary objectives of this study are:
A. To study the alterations of sperm present in infertile men according to the presence of HPV in semen.
B. Identify the specific HPV genotypes involved.
C. To study a potential link between HPV and embryonic characteristics (as classified by Giorgetti)
D. To study a potential link between HPV and survival of the conceptus: products of miscarriage or stillbirth, duration of pregnancy, birth weight.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both members of each couple must have given their free and informed consent and signed the consent
- •Both members of each couple must be members or beneficiaries of a health insurance plan
- •The patient (woman) is available for follow-up after a possible pregnancy
- •The patient (woman) is under 43 years of age
- •The patient (man) is under 60 years of age
- •Couple consulting for infertility services in the participating reproductive medicine centers
排除标准
- •One or both members of the couple are involved in another study
- •One or both members of the couple are in an exclusion period determined by a previous study
- •One or both members of the couple are under judicial protection or under any kind of guardianship
- •One or both members of the couple refuse to sign the consent
- •It is impossible to correctly inform one or both members of the couple
- •The patient (woman) has a contra-indication (or an incompatible combination therapy) for treatment necessary for this study
- •The source of sperm is a donor (i.e. it is not possible to obtain a sperm sample from the biological father for use in HPV testing).
结局指标
主要结局
HPV test for participating women (cervicovaginal sample): positive/negative
时间窗: baseline (day 0)
HPV test for participating men (sperm sample): positive/negative
时间窗: baseline (day 0)
Birth of a living, viable child (yes/no)
时间窗: end of pregnancy (expected maximum of 9 months)
type of medically assisted procreation used
时间窗: baseline (day 0)
次要结局
- HPV genotypes found(baseline (day 0))
- Description of spermogram anomalies(baseline (day 0))
- Embryo score according to Giorgetti et al 1995(Embryo transfer (baseline, day 0))
- Blastocyte score according to Gardner & Schoolcraft 1999(Embryo transfer (baseline, day 0))
- Percentage of implantable embryos(Baseline (day 0))
- BHCG test(Days 13 to 15 after embryo transfer)
- Spontaneous miscarriage before 3 months, yes/no(3 months)
- Pregnancy confirmed via ultrasound, yes/no(12 weeks)
- Spontaneous miscarriage after 3 months, yes/no(end of pregnancy (expected maximum of 9 months))
- Spontaneous miscarriage, yes/no(end of pregnancy (expected maximum of 9 months))
- Days of gestation(end of pregnancy (expected maximum of 9 months))
- Histological and HPV testing on miscarriage samplings(end of pregnancy (expected maximum of 9 months))
- Appearance of fetal malformations (yes/no)(end of pregnancy (expected maximum of 9 months))
- Schieve classification according to weeks of gestation and weight of baby(end of pregnancy (expected maximum of 9 months))
- HPV testing on placenta (positive/negative + genotype)(end of pregnancy (expected maximum of 9 months))
- weight of baby at birth / days of gestation (g/day)(end of pregnancy (expected maximum of 9 months))