Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate (CPR)
研究概览
简要总结
Hypotheses:
We hypothesize that variations in hormonal profiles (LH, estradiol, progesterone) during ovarian stimulation, follicular response, endometrial characteristics, and sperm quality parameters are significantly associated with clinical pregnancy outcomes in intrauterine insemination (IUI) cycles.
Aims
- To investigate the association between hormonal profiles on the trigger day (LH, estradiol, progesterone), follicular response, endometrial thickness, and sperm parameters with clinical pregnancy outcomes in IUI cycles.
- To develop and validate a predictive model for clinical pregnancy incorporating key determinants such as female age, hormonal response, endometrial characteristics, and sperm quality.
- To compare natural and gonadotropin-stimulated IUI cycles in terms of hormonal profiles, pregnancy outcomes, and cost-effectiveness.
Primary Outcome Clinical pregnancy rate (CPR), defined as the presence of a gestational sac with a fetal heartbeat on ultrasound at approximately 6 weeks of gestation following intrauterine insemination.
Secondary Outcomes
- Biochemical pregnancy rate.
- Ongoing pregnancy rate
- Live birth rate
详细描述
Statistical Analysis
Each sub-study will employ specific analytical approaches:
- Univariate and multivariate logistic regression for associations
- Mediation and interaction analysis
- ROC and AUC analysis for predictive modeling
- Machine learning for model development
- Cost-effectiveness evaluated via incremental cost per clinical pregnancy
Consent
This is a retrospective study, and thus, there is no need for a written informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Couples who underwent at least one IUI-intrauterine insemination cycle.
排除标准
- •Couples who used donor sperm.
- •Cases with missing core outcome data
结局指标
主要结局
Clinical pregnancy rate (CPR)
时间窗: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Rate of clinical pregnancy outcome in subjects undergoing IUI
次要结局
- Biochemical pregnancy rate(Up to 12 weeks)
- Ongoing pregnancy rate(Up to 12 weeks)
- live birth rate(Up to 40 weeks)
研究者
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong