The Stanford Egg Freezing Study

NCT05842070 | Completed

• 1 other identifier: 69100
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Issues; Reproductive Issues

Keywords

Access-to-care; Low-cost; Egg freezing; Fertility preservation; Oocyte cryopreservation

Outcome Measures

Primary Outcomes (2)

• Mature oocytes cryopreserved per egg freezing cycle

  Number of mature oocytes cryopreserved

  Identified within 24-48 hours of the oocyte retreival

• Oocyte yield per retrieval or egg freezing cycle

  Number of oocytes retrieved

  Identified within 24 hours of the oocyte retreival

Secondary Outcomes (4)

• 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

• 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

• Additional cost per additional oocytes retrieved

  Identified from post-cycle survey completed 1-2 months following oocyte retrieval

Study Arms (2)

Low-Intensity Protocol

EXPERIMENTAL

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

Procedure: Low-Intensity Egg Freezing Protocol

High-intensity protocol

ACTIVE COMPARATOR

Participants choose a routine high-intensity egg-freezing protocol

Procedure: High-Intensity Egg Freezing Protocol

Interventions

Low-Intensity Egg Freezing Protocol 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.

Also known as: Cardinal Protocol

Low-Intensity Protocol

High-Intensity Egg Freezing Protocol 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.

High-intensity protocol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Fertility and Reproductive Health Services

Sunnyvale, California, 94087, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Ruth Lathi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics & Gynecology

Model Details: A non-inferiority margin of -5 MIIs per retrieval was selected based on existing literature on planned OC, which reports expected yields of 9-13 MIIs with approximately 45% variability in ovarian stimulation response (per literature). Setting the margin at -5 ensured that observed differences in oocyte yield would be beyond expected variation, while still maintaining clinical viability.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 3, 2023
• Study Start: July 26, 2023
• Primary Completion: January 31, 2025
• Study Completion: April 4, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)