Clinical trial NCT05842070: The Stanford Egg Freezing Study
Official title: The Stanford Egg Freezing Study: Investigating a Low-Cost, Low-Intensity Oocyte Cryopreservation Protocol
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fertility Issues
Reproductive Issues
Keywords: Access-to-care
Low-cost
Egg freezing
Fertility preservation
Oocyte cryopreservation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Ovary-bearing individuals of reproductive age 18-40, interested in pursuing OC
* AMH \> 0.3 ng/mL
* AMH \< 7 ng/mL

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oocyte yield per retrieval or egg freezing cycle
timeFrame: Identified within 24 hours of the oocyte retreival
measure: Mature oocytes cryopreserved per egg freezing cycle
timeFrame: Identified within 24-48 hours of the oocyte retreival
Secondary outcomes:
measure: Participant satisfaction with egg freezing experience and specific protocol (assessed using the Likert scale)
timeFrame: Identified on post-cycle survey completed 1-2 months following oocyte retrieval
measure: Out-of-pocket costs of the egg freezing cycle for the participant
timeFrame: Identified on post-cycle survey completed 1-2 months following oocyte retrieval and via the electronic medical record
measure: Time off-work needed to complete the egg freezing cycle
timeFrame: Identified on post-cycle survey completed 1-2 months following oocyte retrieval
measure: Additional cost per additional oocytes retrieved
timeFrame: Identified from post-cycle survey completed 1-2 months following oocyte retrieval
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Stanford Fertility and Reproductive Health Services
state: California
Study officials:
affiliation: Stanford University
name: Ruth Lathi, MD
role: PRINCIPAL_INVESTIGATOR
References: