The Impact of Having a Tattoo on Fertility Treatment Outcome: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Ongoing Pregnancy Rate
研究概览
简要总结
Tattoos are increasingly common among women of reproductive age, yet their potential systemic inflammatory effects and impact on fertility treatment outcomes are unknown. This prospective observational cohort study aims to evaluate whether the presence, size, duration, and ink characteristics of tattoos are associated with pregnancy outcomes following embryo transfer in women undergoing in vitro fertilization (IVF).
详细描述
This is a single-center, prospective observational cohort study conducted at the McGill University Health Centre Reproductive Centre. Women undergoing IVF with planned fresh or frozen blastocyst embryo transfer will be enrolled and categorized based on tattoo presence and characteristics. Tattoo information will be collected using a standardized questionnaire and direct measurement. Participants will be followed for pregnancy and obstetric outcomes through medical chart review. The primary outcome is ongoing pregnancy rate following embryo transfer. Secondary outcomes include clinical pregnancy, biochemical pregnancy, miscarriage, ectopic pregnancy, and live birth.
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
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 21-40 years Undergoing IVF with planned fresh or frozen blastocyst embryo transfer Availability of good-quality blastocyst embryos Willingness to provide informed consent
排除标准
- •Significant untreated uterine abnormalities
- •≥3 prior failed embryo transfers Hydrosalpinx in situ BMI >40 kg/m² Age >41 years at embryo creation Submucosal fibroids in situ Use of medications affecting implantation (e.g., chronic steroids, metformin)
研究组 & 干预措施
Tattoo Group
Participants undergoing IVF with planned embryo transfer who have one or more tattoos at the time of embryo transfer.
No Tattoo Group
Participants undergoing IVF with planned embryo transfer who do not have any tattoos at the time of embryo transfer.
结局指标
主要结局
Ongoing Pregnancy Rate
时间窗: 12 weeks gestation
Presence of fetal heartbeat on ultrasound at ≥12 weeks
次要结局
- Clinical pregnancy rate(6-8 weeks of gestation)
- Biochemical pregnancy(4-5 weeks of gestation)
- Miscarriage rate(before the 20th week of pregnancy)
- Ectopic pregnancy rate(upto 10 weeks of gestation)
- Live birth rate(over 23 weeks of gestation)
研究者
Michael Dahan
MD
McGill University Health Centre/Research Institute of the McGill University Health Centre