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Low vs High-Intensity Egg Freezing for Infertility

N/A

Recruiting

Led By Ruth Lathi, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up identified on post-cycle survey completed 1-2 months following oocyte retrieval

Awards & highlights

Study Summary

This trial will assess a low-cost, low-intensity egg freezing protocol to see if it delivers similar outcomes to high-intensity protocols. It will also measure patient satisfaction, cost, and time off work needed. Results could lead to more affordable and accessible fertility preservation.

Who is the study for?

The Stanford Egg Freezing Study is for ovary-bearing individuals aged 18-40 who want to freeze their eggs and have an Anti-Müllerian Hormone (AMH) level between 0.3 ng/mL and 7 ng/mL. It's not suitable for those with a high risk of severe ovarian hyperstimulation syndrome (OHSS), a BMI over 45, severely low ovarian reserve, or any conditions that make egg retrieval under anesthesia unsafe.Check my eligibility

What is being tested?

This study compares two egg freezing protocols: the Cardinal protocol, which is cost-effective and less intense, versus traditional high-intensity methods used in clinics. Participants will either choose the Cardinal protocol or be assigned the routine method by their physician. The number of eggs retrieved, patient satisfaction, costs involved, and time off work are evaluated.See study design

What are the potential side effects?

While specific side effects aren't detailed here, typical risks may include discomfort from injections during stimulation protocols, bloating, mood swings due to hormonal changes; more serious but rare complications can involve OHSS where ovaries swell painfully and fill with fluid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ identified on post-cycle survey completed 1-2 months following oocyte retrieval

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~identified on post-cycle survey completed 1-2 months following oocyte retrieval

This trial's timeline: 3 weeks for screening, Varies for treatment, and identified on post-cycle survey completed 1-2 months following oocyte retrieval for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mature oocytes cryopreserved per egg freezing cycle

Oocyte yield per retrieval or egg freezing cycle

Secondary outcome measures

Additional cost per additional oocytes retrieved

Out-of-pocket costs of the egg freezing cycle for the participant

Participant satisfaction with egg freezing experience and specific protocol (assessed using the Likert scale)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low-Intensity ProtocolExperimental Treatment1 Intervention

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

Group II: High-intensity protocolActive Control1 Intervention

Participants choose a routine high-intensity egg-freezing protocol

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,250 Total Patients Enrolled

12 Trials studying Infertility

2,285 Patients Enrolled for Infertility

Ruth Lathi, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

300 Total Patients Enrolled

Media Library

High-Intensity Egg Freezing Protocol Clinical Trial Eligibility Overview. Trial Name: NCT05842070 — N/A

Infertility Research Study Groups: Low-Intensity Protocol, High-intensity protocol

Infertility Clinical Trial 2023: High-Intensity Egg Freezing Protocol Highlights & Side Effects. Trial Name: NCT05842070 — N/A

High-Intensity Egg Freezing Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05842070 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this clinical trial?

"In order to be selected for this clinical trial, potential participants must have infertility and fall within the 18-40 year old demographic. The recruitment process is aiming to enrol 100 individuals in total."

Answered by AI

Are investigators still recruiting for this trial?

"The clinicaltrial.gov entry for this trial indicates that it is not actively recruiting patients at present. Despite the study's post date of July 1st 2023 and last update on April 23rd 2023, there are 243 other studies in progress which are currently accepting participants."

Answered by AI

Is the age qualification for this study restricted to those under 35?

"The prerequisites for this medical trial are that patients must be aged between 18 and 40. For minors, there are 11 other trials available whereas those over 65 have 38 options to choose from."

Answered by AI

What key goals are researchers hoping to achieve with this experiment?

"This trial's primary aim, to be determined within 24 hours of the oocyte retrieval timeframe, is assessing mature oocytes cryopreservation per egg freezing cycle. Secondary objectives include quantifying out-of-pocket costs for participants with and without insurance coverage, amount of time off work needed beyond the day of retrieval procedure, as well as additional cost incurred by any extra oocytes retrieved; such analysis will aid in a comprehensive cost-benefit evaluation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Stanford Egg Freezing Study

Ruth Bunker Lathi 2023. "The Stanford Egg Freezing Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05842070.

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