- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03496636
Autologous Ovarian Tissue Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This investigation involves patient enrollment, thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue, a series of follow-up assessments during the first 2 years after transplantation and an annual survey after year 2.
Screening visit (standard fertility consultation):
- The subject will complete a medical and reproductive history to document menstrual function and suitability for pregnancy.
- The subject will have standard fertility testing (including but not limited to serum Follicle Stimulating Hormone (FSH), Estradiol (E2), and Anti-Mullerian Hormone (AMH), luteinizing hormone (LH), testosterone and progesterone).
- Vaginal ultrasound will be performed for measures of ovarian volume and antral follicle counts.
- A pregnancy test will be performed to rule out pregnancy.
- Each potential subject will undergo a comprehensive fertility consult including counseling regarding the extent to which participation in this study might be of ultimate benefit. Alternatives to participation include: continuing to try to conceive on her own, use of donor oocytes or embryos, or adoption.
- The subject will have to obtain clearance from her oncologist and will be counseled by a reproductive endocrinologist to determine whether she is healthy enough to consider pregnancy and to discuss the potential risks and benefits of the study.
Visit #1 - pre-op visit (can be combined with initial screening visit):
Eligible subjects will be consented by the study physician and complete the same infectious disease testing as was performed at the time of ovarian tissue freezing (including but not limited to HIV 1&2, HTLV 1&2, Hepatitis B, Hepatitis C, syphilis, chlamydia, gonorrhea, CMV, West Nile virus). The subjects will also complete Fertility quality of life survey (FertiQoL). FertiQoL is a validated measure of quality of life in people experiencing fertility problems.
Only after confirming eligibility, obtaining informed consent and completing baseline measures, ovarian tissue thawing and transplantation will be performed.
Visit #2 - Ovarian tissue transplantation:
At the time of ovarian tissue thawing, an outpatient laparoscopy (or minilaparotomy if the patient is not deemed to be a good candidate for laparoscopic surgery) will be performed under general anesthesia. Ovarian cortical tissue will be transplanted within the pelvis according to the most effective available techniques.
Visit #3: Post-operative assessment:
Within six weeks of transplant, a postoperative follow-up assessment will be conducted to ensure adequate patient recovery and emotional well-being. Blood tests (including but not limited to serum FSH, E2, and AMH, LH, testosterone and progesterone), pelvic ultrasound and FertiQoL survey, will be conducted to assess reproductive hormone levels, menstrual function, complications from surgery, pregnancy, medical and medication history, and cancer relapse. Referral to the clinical counselor may be made, if indicated.
Visits #4, #5, #6, #7 and #8 at 3, 6, 9, 12 and 24 months post-op:
A series of 5 additional follow-up assessments will be conducted during the first 2 years after transplant with Reproductive Endocrinology and Infertility to assess reproductive hormone levels, menstrual function, complications from surgery, pregnancy, changes in medical and medication status, and cancer relapse. A visit may be added at the time menstruation is restored if this occurs between regularly scheduled visits. At each follow up visit hormone testing is performed, vaginal ultrasound and FertiQoL survey will be administered. Additional clinical follow-up and testing may be determined in consultation with the subject's oncologist.
Annual Survey:
Starting year 3 post-transplantation, each subject will be surveyed annually. The survey is voluntary and confidential and will be conducted by scripted phone interview or self-administered survey through secure email. The survey will include questions about menstrual/pregnancy history, new diagnoses or treatments, and feelings about participating in the study. Detailed information about pregnancy and birth outcomes will be collected by a combination of survey and chart review. Outcome data including remission, relapse or death, will be collected. Contact information will also be updated.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rachel Neelley
- Phone Number: 1 412-641-7475
- Email: fertilitypreservation@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- Magee-Womens Hospital
-
Contact:
- Rachel Neelley
- Phone Number: 1 412-641-7475
- Email: fertilitypreservation@upmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Previously cryopreserved ovarian tissue
- Ovarian insufficiency and/or candidate for pregnancy
- Good health
- Oncologist's clearance
Exclusion Criteria:
- 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
- Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
- Current pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ovarian tissue transplant
Transplantation of ovarian tissue into the abdomen.
Only for patients who have previously frozen ovarian tissue
|
Pieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in reproductive hormone levels after ovarian tissue transplant
Time Frame: 1,3,6,9,12 and 24 months post-transplantation
|
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
|
Return of regular monthly menstrual cycles
Time Frame: Through study completion, up to 15 years
|
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
|
Achievement of successful pregnancy, measured by live birth
Time Frame: Through study completion, up to 15 years
|
Indicates recovery of ovarian function
|
Through study completion, up to 15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer recurrence as determined by patient's oncologist
Time Frame: Through study completion, up to 15 years
|
Indicates cancer recurrence
|
Through study completion, up to 15 years
|
Surgical complications of ovarian tissue transplantation
Time Frame: 1,3,6,9,12 and 24 months post-transplantation
|
Infection, hospital readmission, re-operation
|
1,3,6,9,12 and 24 months post-transplantation
|
Fertility quality of life (FertiQoL) survey results
Time Frame: 1,3,6,9,12 and 24 months post-transplantation
|
Measure quality of life in individuals experiencing fertility problems
|
1,3,6,9,12 and 24 months post-transplantation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kyle Orwig, PhD, University of Pittsburgh/University of Pittsburgh Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Infertility
- Primary Ovarian Insufficiency
- Menopause, Premature
- Infertility, Female
Other Study ID Numbers
- PRO17120172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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