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Recruiting NCT01870752

Ovarian Tissue Transplantation

No phase Interventional Infertile Females or Females With Ovarian Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transplantation of previously cryopreserved ovarian tissu.
Who it may be relevant to
Registry conditions: Infertile Females or Females With Ovarian Insufficiency. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue

Overview

Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.

Interventions

  • Procedure Transplantation of previously cryopreserved ovarian tissu

Primary outcome measures

  • Pregnancy [Time frame: 5 years]
  • Return of menstrual function [Time frame: 5 years]
Secondary outcome measures (3)
  • Cancer recurrence [Time frame: 5 years]
  • Surgical Complications of ovarian tissue transplantation [Time frame: 5 years]
  • Acceptability [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Female patient between the ages of 18 and 45 years
  • Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
  • Ovarian insufficiency defined as an elevated FSH over 10
  • Inability to conceive after 6 months of unprotected intercourse with male
  • Reasonably good health
  • Candidate for pregnancy
  • Written clearance for the procedure from the patients oncologist

Exclusion criteria

  • Patients considered to be high risk for surgical complications will be excluded from the research protocol
  • 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
  • Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
  • Current pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Abramson Cancer Center of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT01870752 · UPCC 02813

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗