Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- sustained implantation rate
研究概览
简要总结
The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.
详细描述
The objective of this study is to conduct a double-blind prospective randomized control trial to determine if individualized hCG titration based on a patient's serum hCG level above or below the predetermined serum hCG level improves IVF outcomes, primarily sustained implantation rates. Patients who fall below the desired serum hCG threshold will be randomized to either maintaining their current dose of low dose hCG or being increased.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients whose physicians plan to prescribe low-dose hCG for ovarian stimulation
- •Negative serum hCG prior to start of COH
- •BMI >18 and <35
- •Plan for ejaculated sperm use
- •Plan for PGT testing with euploid embryo transfer
排除标准
- •Administration of low-dose hCG during frozen embryo transfer cycle
- •Concomitant Menopur administration during ovarian stimulation or during frozen embryo transfer cycle
- •BMI <18 or >35
- •Age <18 or >46
- •Presence of hydrosalpinxes that communicate with the endometrial cavity
- •Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), and persistent endometrial fluid
- •Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
- •Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- •Use of surgical procedures to obtain sperm
- •Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
- •Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
- •Declination of PGT testing
结局指标
主要结局
sustained implantation rate
时间窗: 8 weeks gestational age
presence of fetal heart beat upon discharge
次要结局
未报告次要终点