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Ovarian Tissue Freezing for Infertility
Phase 4
Recruiting
Led By David M Lee, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For patients undergoing elective removal of an ovary for fertility preservation only, have two ovaries
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test whether it's possible to store a woman's ovarian tissue so that it can be thawed and transplanted back at a later date, preserving her fertility.
Who is the study for?
This trial is for women aged 18-41 who may lose ovarian function due to medical treatments like surgery, chemotherapy, or radiation for conditions such as cancer. It's also open to those needing ovary removal and have not had previous therapy likely to cause permanent ovarian damage. Participants must be able to give informed consent.
What is being tested?
The study tests the preservation of fertility through freezing ovarian tissue before treatments that could harm the ovaries. The goal is to see if human eggs can survive and function after being stored in frozen state long-term.
What are the potential side effects?
Potential side effects are related mainly to the surgical procedure required for tissue collection, which includes risks associated with anesthesia, infection at the surgery site, bleeding, and pain post-operation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have two ovaries and am planning to preserve fertility by removing one.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CryopreservationExperimental Treatment1 Intervention
The ovarian tissue is frozen and banked at the in vitro fertilization lab at the Center for Health and Healing at OHSU.
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,164 Total Patients Enrolled
David M Lee, MD5.063 ReviewsPrincipal Investigator - Oregon Health and Sciences University
Scottsdale Healthcare Shea
Medical School - Yale University
University of Washington, Residency in Otolaryngology and Head and Neck Surgery
5Patient Review
I found Dr. Lykins to be both amiable and well-informed. He put me at ease with his comforting presence.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 18-41 facing treatments that may affect my ovarian function or require ovary removal.My ovarian disease is either new or has come back, and I haven't had treatments that would stop my ovaries from working forever.I have two ovaries and am planning to preserve fertility by removing one.My health condition makes anesthesia and surgery very risky for me.I have my ovarian tissue frozen before starting cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cryopreservation
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.