Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Institutional Review Board (IRB) protocol is being designed to offer ovarian tissue cryopreservation to female pediatric patients (birth-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential. Because this procedure is currently considered experimental, the establishment of an IRB protocol under which this opportunity can be offered is needed.
Ovarian tissue cryopreservation is currently considered experimental but offers the only opportunity for fertility preservation in pre-menarchal girls faced with a fertility threatening diagnosis or treatment plan.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian tissue cryopreservation | Experimental | Children faced with a fertility threatening diagnosis or treatment plan will be offered ovarian tissue cryopreservation, particularly if pre menarchal and without other options to preserve fertility. Although considered experimental, there are over 120 live births worldwide using this technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovarian tissue cryopreservation | Procedure | Ovarian tissue will be removed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of pregnancy and live births after transplantation of cryopreserved ovarian tissue | 10-20 years |
Not provided
Not provided
Inclusion Criteria: (All inclusion criteria must be met.)
Female, age birth-17 years
Meet at least one of the following three conditions:
For patients undergoing elective removal of all or part of an ovary for fertility preservation only, they must have two ovaries.
Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
Exclusion Criteria: (Any exclusion criteria will disqualify.)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zaraq Khan, M.B.B.S. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33910089 | Derived | Joshi VB, Behl S, Pittock ST, Arndt CAS, Zhao Y, Khan Z, Granberg CF, Chattha A. Establishment of a Pediatric Ovarian and Testicular Cryopreservation Program for Malignant and Non-Malignant Conditions: The Mayo Clinic Experience. J Pediatr Adolesc Gynecol. 2021 Oct;34(5):673-680. doi: 10.1016/j.jpag.2021.04.006. Epub 2021 Apr 25. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided