The Stanford Egg Freezing Study

NCT ID: NCT05842070

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2025-04-04

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.

Conditions

Fertility Issues; Reproductive Issues

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-Intensity Protocol

Participants choose the low-cost, low-intensity egg-freezing protocol

Group Type: EXPERIMENTAL

Low-Intensity Egg Freezing Protocol

Intervention Type: PROCEDURE

The low-intensity egg freezing protocol involves fewer ultrasounds, bloodwork and injections, contributing to a lower cost. Otherwise, this protocol does not differ significantly from the other routine high-intensity clinic protocols.

High-intensity protocol

Participants choose a routine high-intensity egg-freezing protocol

Group Type: ACTIVE_COMPARATOR

High-Intensity Egg Freezing Protocol

Intervention Type: PROCEDURE

The high-intensity egg freezing protocol is a routinely used clinic protocol where patients are coming for frequent ultrasounds and bloodwork, as well as more injections, contributing to a higher overall cost for egg-freezing.

Interventions

High-Intensity Egg Freezing Protocol

The high-intensity egg freezing protocol is a routinely used clinic protocol where patients are coming for frequent ultrasounds and bloodwork, as well as more injections, contributing to a higher overall cost for egg-freezing.

Intervention Type: PROCEDURE

Low-Intensity Egg Freezing Protocol

The low-intensity egg freezing protocol involves fewer ultrasounds, bloodwork and injections, contributing to a lower cost. Otherwise, this protocol does not differ significantly from the other routine high-intensity clinic protocols.

Intervention Type: PROCEDURE

Other Intervention Names

Cardinal Protocol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Ruth Bunker Lathi

Professor of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruth Lathi, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Fertility and Reproductive Health Services

Sunnyvale, California, United States

Countries

United States

Other Identifiers

69100

Identifier Type: -

Identifier Source: org_study_id