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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 below
Select...
I have two ovaries and am planning to preserve fertility by removing one.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
1,006 Previous Clinical Trials
7,413,947 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

Ovarian Tissue Freezing (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00902720 — Phase 4
Cancer Research Study Groups: Cryopreservation
Cancer Clinical Trial 2023: Ovarian Tissue Freezing Highlights & Side Effects. Trial Name: NCT00902720 — Phase 4
Ovarian Tissue Freezing (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00902720 — Phase 4
~0 spots leftby Mar 2025
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