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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05842070
Other study ID # 69100
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 26, 2023
Est. completion date July 2025

Study information

Verified date August 2023
Source Stanford University
Contact Esther Chung, MD
Phone 8449962059
Email echung1@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Stanford Fertility and Reproductive Health Services Sunnyvale California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oocyte yield per retrieval or egg freezing cycle Number of oocytes retrieved Identified within 24 hours of the oocyte retreival
Primary Mature oocytes cryopreserved per egg freezing cycle Number of mature oocytes cryopreserved Identified within 24-48 hours of the oocyte retreival
Secondary 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 Identified on post-cycle survey completed 1-2 months following oocyte retrieval
Secondary 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 Identified on post-cycle survey completed 1-2 months following oocyte retrieval and via the electronic medical record
Secondary Time off-work needed to complete the egg freezing cycle Not including the egg retrieval procedure day Identified on post-cycle survey completed 1-2 months following oocyte retrieval
Secondary Additional cost per additional oocytes retrieved Cost-benefit analyses Identified from post-cycle survey completed 1-2 months following oocyte retrieval
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