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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mature oocytes cryopreserved per egg freezing cycle
Oocyte yield per retrieval or egg freezing cycle
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,469 Previous Clinical Trials
17,501,647 Total Patients Enrolled
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
Reproductive Issues Research Study Groups: Low-Intensity Protocol, High-intensity protocol
Reproductive Issues 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
~6 spots leftby Jan 2025
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