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Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue


N/A
18 Years
45 Years
Open (Enrolling)
Female
Infertile Females or Females With Ovarian Insufficiency

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Trial Information

Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Clarisa R Gracia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 02813

NCT ID:

NCT01870752

Start Date:

June 2013

Completion Date:

June 2018

Related Keywords:

  • Infertile Females or Females With Ovarian Insufficiency
  • Infertility
  • Menopause, Premature
  • Primary Ovarian Insufficiency

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283