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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03496636
Other study ID # PRO17120172
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date September 1, 2027

Study information

Verified date May 2024
Source University of Pittsburgh
Contact Rachel Neelley
Phone 412-641-7475
Email fertilitypreservation@upmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Procedure:
Ovarian tissue transplant
Pieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy

Locations

Country Name City State
United States Magee-Womens Hospital Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in reproductive hormone levels after ovarian tissue transplant Measure of reproductive hormone levels (FSH, AMH, LH E2 and others) to detect graft function 1,3,6,9,12 and 24 months post-transplantation
Primary 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. Through study completion, up to 15 years
Primary Achievement of successful pregnancy, measured by live birth Indicates recovery of ovarian function Through study completion, up to 15 years
Secondary Cancer recurrence as determined by patient's oncologist Indicates cancer recurrence Through study completion, up to 15 years
Secondary Surgical complications of ovarian tissue transplantation Infection, hospital readmission, re-operation 1,3,6,9,12 and 24 months post-transplantation
Secondary Fertility quality of life (FertiQoL) survey results Measure quality of life in individuals experiencing fertility problems 1,3,6,9,12 and 24 months post-transplantation
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