Autologous Ovarian Tissue Transplantation
ConditionFemale Infertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Pittsburgh
About this trial
Chemotherapy and radiation for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). The objective of this study is to study the efficacy and safety of autologous tissue transplantation in patients diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previously cryopreserved ovarian tissue
Ovarian insufficiency and/or candidate for pregnancy
Good health
Oncologist's clearance
Disqualifiers
Patients considered to be high risk for surgical complications
Women with contraindication for pregnancy if goal is to achieve pregnancy
Women positive for the BRCA mutations
Women with a history of leukemia, ovarian cancer or a cancer that likely involved ovaries at the time of ovarian tissue collection
Trial design
Design model
Single group
Treatments tested in this trial
Ovarian tissue transplant
Procedure/SurgeryPieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Ovarian tissue transplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in reproductive hormone levels after ovarian tissue transplant
Measure of reproductive hormone levels (FSH, AMH, LH E2 and others) to detect graft function
Time frame
1,3,6,9,12 and 24 months post-transplantation2
Return of regular monthly menstrual cycles
Onset of regular monthly menstrual cycles after transplantation would indicate graft function. This needs to be analyzed at multiple time points to assess if regular monthly menstrual cycles have ceased, which could indicate graft failure.
Time frame
Through study completion, up to 15 years3
Achievement of successful pregnancy, measured by live birth
Indicates recovery of ovarian function
Time frame
Through study completion, up to 15 yearsSecondary outcomes
1
Cancer recurrence as determined by patient's oncologist
Indicates cancer recurrence
Time frame
Through study completion, up to 15 years2
Surgical complications of ovarian tissue transplantation
Infection, hospital readmission, re-operation
Time frame
1,3,6,9,12 and 24 months post-transplantation3
Fertility quality of life (FertiQoL) survey results
Measure quality of life in individuals experiencing fertility problems
Time frame
1,3,6,9,12 and 24 months post-transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov