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Procedure

Ovarian Tissue Transplantation for Female Infertility

N/A
Recruiting
Led By Clarisa R Gracia, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patient between the ages of 18 and 45 years
Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
Must not have
Women who are known to be positive for the BRCA mutation
Women with a history of leukemia, ovarian cancer, or a cancer that likely involved the ovaries at the time of ovarian tissue collection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether ovarian tissue that has been frozen can be thawed and transplanted back to the patient, restoring fertility. The trial is also testing the safety of this procedure.

Who is the study for?
This trial is for women aged 18-45 who have become infertile or have ovarian insufficiency due to cancer treatments. They must have their own frozen ovarian tissue, be in good health, and unable to conceive naturally after trying for 6 months. Women with high surgical risk, current pregnancy, BRCA mutation, certain cancers or mental conditions affecting consent are excluded.
What is being tested?
The study tests the safety and effectiveness of transplanting a woman's own previously frozen ovarian tissue back into her body. This aims to restore fertility in those affected by infertility or ovarian failure post-cancer treatment.
What are the potential side effects?
Potential side effects may include complications from surgery such as infection or bleeding, hormonal changes due to restored ovarian function, and possible re-introduction of cancer cells if present in the transplanted tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 18 and 45.
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I have my ovarian tissue frozen for future use.

Exclusion Criteria

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

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
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: Transplantation of previously cryopreserved ovarian tissueExperimental Treatment1 Intervention
Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,494 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
164,621 Total Patients Enrolled
Clarisa R Gracia, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine

Media Library

Transplantation of previously cryopreserved ovarian tissue (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01870752 — N/A
Female Infertility or Ovarian Insufficiency. Research Study Groups: Transplantation of previously cryopreserved ovarian tissue
Female Infertility or Ovarian Insufficiency. Clinical Trial 2023: Transplantation of previously cryopreserved ovarian tissue Highlights & Side Effects. Trial Name: NCT01870752 — N/A
Transplantation of previously cryopreserved ovarian tissue (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01870752 — N/A
~2 spots leftby Jun 2028
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