The Stanford Egg Freezing Study: Investigating a Low-Cost, Low-Intensity Oocyte Cryopreservation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Mature oocytes cryopreserved per egg freezing cycle
研究概览
简要总结
The purpose of this study is to see if the investigators can obtain non-inferior clinical outcomes (similar numbers of oocytes) using the Cardinal protocol, a cost-conscious, low-intensity egg freezing protocol, compared to other routinely used high-intensity clinic protocols. This is a new program for Stanford's Fertility Clinic, so the investigators are assessing patient experience and cost-benefit of a low-cost, low-intensity approach that has demonstrated non-inferiority in IVF for infertility treatment, but has not been similarly evaluated in egg freezing. All enrolled participants will choose the Cardinal protocol or the routine high-intensity protocol designated by their physician. The investigators will then assess number of eggs retrieved, as well as patient satisfaction, cost, and time needed off work to complete the egg freezing cycle. The study's findings could ultimately open the door to implementation of lower-cost standardized protocols that would be more affordable and accessible to people who may otherwise not be able to pursue fertility preservation.
详细描述
The 2020-2025 strategic plan of ASRM lists equitable, affordable access to reproductive healthcare as a high-focus priority goal, with a pressing need to identify cost-effective treatments that patients shut out by finances can still afford. While there have been some efforts made to broaden access to infertility treatment with in-vitro fertilization (IVF), there are very limited efforts to do for patients desiring egg freezing as a strategy for deferred reproduction. The Stanford Egg Freezing Study is a novel clinical trial that will be assessing for non-inferiority of outcomes from a low-cost, low-intensity approach called the Cardinal Protocol, compared to the routinely used high-intensity clinic protocols. Participant enrollment will occur locally in the greater Bay Area from patients pursuing egg freezing for fertility preservation at Stanford's Fertility clinic.
To specifically review the Cardinal Protocol, this is a low-cost, low-intensity egg-freezing protocol designed to be cost-conscious and streamlined compared to all the other routine protocols used in clinic. This means medication doses are protocolized, decreasing the total number of injections and medications needed, bloodwork and ultrasounds are limited, prevention of premature ovulation is done using oral progestins, and trigger timing is standardized as opposed to timed by provider preference, resulting in a projected cost-savings of on average $5,800 ($3,700-$11,000). This protocol has been reviewed and approved by all 8 REI board-certified infertility specialists at Stanford who based on the literature and practice deem this a standard protocol that could be offered to patients interested in a lower-cost approach.
The investigators hypothesize that the Cardinal protocol compared to the other routinely used high-intensity clinic protocols, will offer non-inferior clinical outcomes for patients with respect to the number of eggs retrieved, improve overall patient satisfaction, and decrease out-of-pocket costs, as well as time required off work to complete the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ovary-bearing individuals of reproductive age 18-40, interested in pursuing OC
- •AMH > 0.3 ng/mL
- •AMH < 7 ng/mL
排除标准
- •AMH > 7 ng/mL or physician concern for risk of developing severe OHSS
- •History of severe OHSS
- •Severe diminished ovarian reserve (DOR) def. as AMH < 0.3 ng/mL or FSH > 15
- •BMI > 45
- •Any contraindications to ovarian stimulation or outpatient egg retrieval under anesthesia
结局指标
主要结局
Mature oocytes cryopreserved per egg freezing cycle
时间窗: Identified within 24-48 hours of the oocyte retreival
Number of mature oocytes cryopreserved
Oocyte yield per retrieval or egg freezing cycle
时间窗: Identified within 24 hours of the oocyte retreival
Number of oocytes retrieved
次要结局
- Out-of-pocket costs of the egg freezing cycle for the participant(Identified on post-cycle survey completed 1-2 months following oocyte retrieval and via the electronic medical record)
- Time off-work needed to complete the egg freezing cycle(Identified on post-cycle survey completed 1-2 months following oocyte retrieval)
- Participant satisfaction with egg freezing experience and specific protocol (assessed using the Likert scale)(Identified on post-cycle survey completed 1-2 months following oocyte retrieval)
- Additional cost per additional oocytes retrieved(Identified from post-cycle survey completed 1-2 months following oocyte retrieval)
研究者
Ruth Bunker Lathi
Professor of Obstetrics & Gynecology
Stanford University