Fertility IssuesNCT05842070
The Stanford Egg Freezing Study
A study testing Low-Intensity Egg Freezing Protocol and High-Intensity Egg Freezing Protocol in people with Fertility Issues and Reproductive Issues, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fertility Issues, Reproductive Issues
- What is being tested?
- Low-Intensity Egg Freezing Protocol and High-Intensity Egg Freezing Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2023to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ovary-bearing individuals of reproductive age 18-40, interested in pursuing OC
- AMH > 0.3 ng/mL
- AMH < 7 ng/mL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Fertility and Reproductive Health Services
Sunnyvale, California, 94087
About this study
Official title: The Stanford Egg Freezing Study: Investigating a Low-Cost, Low-Intensity Oocyte Cryopreservation Protocol
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.
Read the 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
- Being tested
- Low-Intensity Egg Freezing Protocol, High-Intensity Egg Freezing Protocol
- Keywords
- Access-to-care, Low-cost, Egg freezing, Fertility preservation, Oocyte cryopreservation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Egg Freezing ProtocolProcedure or surgery
Also called Cardinal 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 ProtocolProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Protocol | Experimental | Participants choose the low-cost, low-intensity egg-freezing protocol Receives: Procedure: Low-Intensity Egg Freezing Protocol |
| High-intensity protocol | Active comparator | Participants choose a routine high-intensity egg-freezing protocol Receives: Procedure: High-Intensity Egg Freezing Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mature oocytes cryopreserved per egg freezing cycle
Number of mature oocytes cryopreserved
Measured: Identified within 24-48 hours of the oocyte retreival
Oocyte yield per retrieval or egg freezing cycle
Number of oocytes retrieved
Measured: 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)
Assessment of satisfaction on scale of 1-5 towards egg freezing process and protocol
Measured: Identified on post-cycle survey completed 1-2 months following oocyte retrieval
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
Measured: 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
Not including the egg retrieval procedure day
Measured: Identified on post-cycle survey completed 1-2 months following oocyte retrieval
Additional cost per additional oocytes retrieved
Cost-benefit analyses
Measured: Identified from post-cycle survey completed 1-2 months following oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start26 Jul 2023
- Primary completion31 Jan 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Bunker Lathi, Stanford University
- Investigators
- Ruth Lathi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842070
- Sponsor's protocol ID
- 69100
- Status last verified
- Jan 2026
- First submitted
- 6 Apr 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung EH, Raj-Derouin N, Zhang J, Harbour V, Markwei M, Khorshid A, Bavan B, Aghajanova L, Lathi RB. The Cardinal protocol: investigating a simplified, cost-conscious option for oocyte cryopreservation in a prospective noninferiority cohort study. F S Rep. 2026 May 8;7(4):301-312. doi: 10.1016/j.xfre.2026.05.001. eCollection 2026 Aug.
PubMed 42630557
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stanford Egg Freezing Study: Investigating a Low-Cost, Low-Intensity Oocyte Cryopreservation Protocol
- ClinicalTrials.gov ID
- NCT05842070
- Acronym / sponsor ID
- 69100
- Conditions
- Fertility Issues, Reproductive Issues
- Keywords
- Access-to-care, Low-cost, Egg freezing, Fertility preservation, Oocyte cryopreservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Protocol | Experimental | Procedure: Low-Intensity Egg Freezing ProtocolParticipants choose the low-cost, low-intensity egg-freezing protocol |
| High-intensity protocol | Active comparator | Procedure: High-Intensity Egg Freezing ProtocolParticipants choose a routine high-intensity egg-freezing protocol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ovary-bearing individuals of reproductive age 18-40, interested in pursuing OC
- AMH > 0.3 ng/mL
- AMH < 7 ng/mL
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Egg Freezing ProtocolAlso: Cardinal ProtocolThe 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. | Procedure or surgery | Low-Intensity Protocol |
| High-Intensity Egg Freezing ProtocolThe 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. | Procedure or surgery | High-intensity protocol |
Primary outcome
Mature oocytes cryopreserved per egg freezing cycle
Time frame: Identified within 24-48 hours of the oocyte retreival
Number of mature oocytes cryopreserved
Oocyte yield per retrieval or egg freezing cycle
Time frame: Identified within 24 hours of the oocyte retreival
Number of oocytes retrieved
4 secondary outcomes
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
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
Time off-work needed to complete the egg freezing cycle
Time frame: Identified on post-cycle survey completed 1-2 months following oocyte retrieval
Additional cost per additional oocytes retrieved
Time frame: Identified from post-cycle survey completed 1-2 months following oocyte retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Derived from this study: PubMed 42630557Chung EH, Raj-Derouin N, Zhang J, Harbour V, Markwei M, Khorshid A, Bavan B, Aghajanova L, Lathi RB. The Cardinal protocol: investigating a simplified, cost-conscious option for oocyte cryopreservation in a prospective noninferiority cohort study. F S Rep. 2026 May 8;7(4):301-312. doi: 10.1016/j.xfre.2026.05.001. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Lathi, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Egg Freezing Protocol and High-Intensity Egg Freezing Protocol in people with Fertility Issues and Reproductive Issues, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mature oocytes cryopreserved per egg freezing cycle (time frame: Identified within 24-48 hours of the oocyte retreival). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.