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The Stanford Egg Freezing Study

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ClinicalTrials.gov Identifier: NCT05842070
Recruitment Status : Recruiting
First Posted : May 3, 2023
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
Ruth Bunker Lathi, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fertility Issues Reproductive Issues Procedure: Low-Intensity Egg Freezing Protocol Procedure: High-Intensity Egg Freezing Protocol Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Stanford Egg Freezing Study: Investigating a Low-Cost, Low-Intensity Oocyte Cryopreservation Protocol
Actual Study Start Date : July 26, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : July 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low-Intensity Protocol
Participants choose the low-cost, low-intensity egg-freezing protocol
 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.
Other Name: Cardinal Protocol
Active Comparator: High-intensity protocol
Participants choose a routine high-intensity egg-freezing protocol
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Oocyte yield per retrieval or egg freezing cycle [ Time Frame: Identified within 24 hours of the oocyte retreival ]
    Number of oocytes retrieved

  2. Mature oocytes cryopreserved per egg freezing cycle [ Time Frame: Identified within 24-48 hours of the oocyte retreival ]
    Number of mature oocytes cryopreserved


Secondary Outcome Measures :
  1. Participant satisfaction with egg freezing experience and specific protocol (assessed using the Likert scale) [ Time Frame: Identified on post-cycle survey completed 1-2 months following oocyte retrieval ]
    Assessment of satisfaction on scale of 1-5 towards egg freezing process and protocol

  2. Out-of-pocket costs of the egg freezing cycle for the participant [ Time Frame: Identified on post-cycle survey completed 1-2 months following oocyte retrieval and via the electronic medical record ]
    With or without insurance coverage for egg freezing, with an assessment of total costs or charges of the cycle, including medication costs

  3. Time off-work needed to complete the egg freezing cycle [ Time Frame: Identified on post-cycle survey completed 1-2 months following oocyte retrieval ]
    Not including the egg retrieval procedure day

  4. Additional cost per additional oocytes retrieved [ Time Frame: Identified from post-cycle survey completed 1-2 months following oocyte retrieval ]
    Cost-benefit analyses


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05842070


Contacts
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Contact: Esther Chung, MD 8449962059 echung1@stanford.edu

Locations
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United States, California
Stanford Fertility and Reproductive Health Services Recruiting
Sunnyvale, California, United States, 94087
Contact: Study Team    650-498-7911    echung1@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Ruth Lathi, MD Stanford University
More Information
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Responsible Party: Ruth Bunker Lathi, Professor of Obstetrics & Gynecology, Stanford University
ClinicalTrials.gov Identifier: NCT05842070    
Other Study ID Numbers: 69100
First Posted: May 3, 2023    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruth Bunker Lathi, Stanford University:
Access-to-care
Low-cost
Egg freezing
Fertility preservation
Oocyte cryopreservation
Additional relevant MeSH terms:
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Infertility
Genital Diseases
Urogenital Diseases