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Procedure

Autologous Ovarian Tissue Transplant for Infertility

N/A
Recruiting
Led By Kyle Orwig, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously cryopreserved ovarian tissue
Be between 18 and 65 years old
Must not have
Women with a history of leukemia, ovarian cancer or a cancer that likely involved ovaries at the time of ovarian tissue collection
Women positive for the BRCA mutations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether it is safe to give patients their own frozen ovarian tissue after chemotherapy and/or radiation treatments for cancer.

Who is the study for?
This trial is for women who have lost their fertility due to cancer treatments like chemotherapy or radiation and had previously frozen ovarian tissue. They must be in good health, cleared by an oncologist, and either have primary ovarian insufficiency or wish to become pregnant. Women at high surgical risk, with pregnancy contraindications, BRCA mutations, certain cancers, psychological issues preventing consent, or current pregnancy cannot join.
What is being tested?
The study tests the effectiveness and safety of transplanting a woman's own previously frozen ovarian tissue back into her body. This procedure aims to restore fertility in women who became infertile after receiving cancer treatment.
What are the potential side effects?
Potential side effects may include typical risks associated with surgical procedures such as infection, bleeding, pain at the transplantation site; hormonal changes; and possible failure to restore fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have my ovarian tissue frozen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of leukemia, ovarian cancer, or a cancer that affected my ovaries.
Select...
I have tested positive for BRCA mutations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achievement of successful pregnancy, measured by live birth
Change in reproductive hormone levels after ovarian tissue transplant
Return of regular monthly menstrual cycles
Secondary study objectives
Cancer recurrence as determined by patient's oncologist
Fertility quality of life (FertiQoL) survey results
Surgical complications of ovarian tissue transplantation

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ovarian tissue transplantExperimental Treatment1 Intervention
Transplantation of ovarian tissue into the abdomen. Only for patients who have previously frozen ovarian tissue

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,618 Total Patients Enrolled
1 Trials studying Primary Ovarian Insufficiency
13 Patients Enrolled for Primary Ovarian Insufficiency
Kyle Orwig, PhDPrincipal Investigator - University of Pittsburgh/University of Pittsburgh Medical Center
University of Pittsburgh
7 Previous Clinical Trials
1,926 Total Patients Enrolled

Media Library

Ovarian tissue transplant (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03496636 — N/A
Primary Ovarian Insufficiency Research Study Groups: Ovarian tissue transplant
Primary Ovarian Insufficiency Clinical Trial 2023: Ovarian tissue transplant Highlights & Side Effects. Trial Name: NCT03496636 — N/A
Ovarian tissue transplant (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03496636 — N/A
~2 spots leftby Sep 2026
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