A Study of Ovarian Tissue Freezing for the Preservation of Fertility in Children

Overview

About this study

The purpose of this study is 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. Since this procedure is currently considered experimental, the establishment of an IRB protocol under which this opportunity can be offered is needed.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Female patient, age birth - 17 years old.
  • Have a diagnosis of a medical condition that is expected to result in permanent diminished or complete loss of subsequent ovarian function (e.g. Turner’s syndrome); OR
  • Have a diagnosis that will create a need for surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of the condition (e.g., lupus nephritis) or malignancy and is expected to result in permanent diminished or complete loss of subsequent ovarian function. Unlike in males where a semen analysis provides an objective measure of testicular function, ovarian reserve testing remains subjective by evaluation of hormones. Therefore, to objectively qualify a degree of expected diminished loss of fertility is difficult. We have attached a supporting document outlining the chemotherapeutic agents which can results in moderate to high risk of gonadotoxicity; OR
  • Have a medical condition or malignancy that requires removal of all or part of one or both ovaries. Girls with ovarian or germ cell tumors requiring removal of all or part of one or both ovaries will also be eligible for inclusion in the study; OR
  • Have a newly diagnosed or recurrent disease affecting fertility.
  • 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:

  • Girls with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  • Girls whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
  • Subjects with extensive disease whose therapy is deemed palliative by the medical oncologist will not be selected.
  • Subjects with suspected severe diminished ovarian reserve, such as a follicle stimulating hormone (FSH) level of >40.

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Zaraq Khan, M.B.B.S.

Open for enrollment

Contact information:

Vidhu Joshi

(507)538-5772

Joshi.Vidhu@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20267872

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