Health TrialsbyHealthPanel

Ovarian Tissue Transplantation

ConditionInfertile Females or Females With Ovarian Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Transplantation of previously cryopreserved ovarian tissu

    Procedure/Surgery

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Transplantation of previously cryopreserved ovarian tissueOther 1 intervention

Trial outcomes

Primary outcomes

1

Pregnancy

Time frame
5 years
2

Return of menstrual function

Time frame
5 years

Secondary outcomes

1

Cancer recurrence

Time frame
5 years
2

Surgical Complications of ovarian tissue transplantation

Including infection, hospital readmission, re-operation

Time frame
5 years
3

Acceptability

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

Source ClinicalTrials.gov
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