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The Stanford Egg Freezing Study

Primary Purpose

Fertility Issues, Reproductive Issues

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Intensity Egg Freezing Protocol
High-Intensity Egg Freezing Protocol
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertility Issues focused on measuring Access-to-care, Low-cost, Egg freezing, Fertility preservation, Oocyte cryopreservation

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Fertility and Reproductive Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-Intensity Protocol

High-intensity protocol

Arm Description

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

Participants choose a routine high-intensity egg-freezing protocol

Outcomes

Primary Outcome Measures

Oocyte yield per retrieval or egg freezing cycle
Number of oocytes retrieved
Mature oocytes cryopreserved per egg freezing cycle
Number of mature oocytes cryopreserved

Secondary Outcome Measures

Participant satisfaction with egg freezing experience and specific protocol (assessed using the Likert scale)
Assessment of satisfaction on scale of 1-5 towards egg freezing process and protocol
Out-of-pocket costs of the egg freezing cycle for the participant
With or without insurance coverage for egg freezing, with an assessment of total costs or charges of the cycle, including medication costs
Time off-work needed to complete the egg freezing cycle
Not including the egg retrieval procedure day
Additional cost per additional oocytes retrieved
Cost-benefit analyses

Full Information

First Posted
April 6, 2023
Last Updated
August 11, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05842070
Brief Title
The Stanford Egg Freezing Study
Official Title
The Stanford Egg Freezing Study: Investigating a Low-Cost, Low-Intensity Oocyte Cryopreservation Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Issues, Reproductive Issues
Keywords
Access-to-care, Low-cost, Egg freezing, Fertility preservation, Oocyte cryopreservation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Intensity Protocol
Arm Type
Experimental
Arm Description
Participants choose the low-cost, low-intensity egg-freezing protocol
Arm Title
High-intensity protocol
Arm Type
Active Comparator
Arm Description
Participants choose a routine high-intensity egg-freezing protocol
Intervention Type
Procedure
Intervention Name(s)
Low-Intensity Egg Freezing Protocol
Other Intervention Name(s)
Cardinal Protocol
Intervention Description
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
Intervention Name(s)
High-Intensity Egg Freezing Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oocyte yield per retrieval or egg freezing cycle
Description
Number of oocytes retrieved
Time Frame
Identified within 24 hours of the oocyte retreival
Title
Mature oocytes cryopreserved per egg freezing cycle
Description
Number of mature oocytes cryopreserved
Time Frame
Identified within 24-48 hours of the oocyte retreival
Secondary Outcome Measure Information:
Title
Participant satisfaction with egg freezing experience and specific protocol (assessed using the Likert scale)
Description
Assessment of satisfaction on scale of 1-5 towards egg freezing process and protocol
Time Frame
Identified on post-cycle survey completed 1-2 months following oocyte retrieval
Title
Out-of-pocket costs of the egg freezing cycle for the participant
Description
With or without insurance coverage for egg freezing, with an assessment of total costs or charges of the cycle, including medication costs
Time Frame
Identified on post-cycle survey completed 1-2 months following oocyte retrieval and via the electronic medical record
Title
Time off-work needed to complete the egg freezing cycle
Description
Not including the egg retrieval procedure day
Time Frame
Identified on post-cycle survey completed 1-2 months following oocyte retrieval
Title
Additional cost per additional oocytes retrieved
Description
Cost-benefit analyses
Time Frame
Identified from post-cycle survey completed 1-2 months following oocyte retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Chung, MD
Phone
8449962059
Email
echung1@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Lathi, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Fertility and Reproductive Health Services
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94087
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Team
Phone
650-498-7911
Email
echung1@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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