Ovarian Tissue Cryopreservation for Pediatric Cancer Patients

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Psychiatric conditions, Anesthesia risk, Palliative therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ovarian tissue cryopreservation for pediatric cancer patients?

Research shows that ovarian tissue cryopreservation can preserve fertility in young girls undergoing cancer treatment, as it has been successfully used in cases involving children as young as 1 to 3 years old. Additionally, studies indicate that this method can restore ovarian function after treatment, offering hope for future fertility. ^{1 2 3 4 5}

Is ovarian tissue cryopreservation safe for pediatric cancer patients?

Ovarian tissue cryopreservation has been used safely in children and adolescents undergoing cancer treatment, with no major complications reported and no delay in chemotherapy. It is considered a safe option for preserving fertility in young patients. ^{2 4 6 7 8}

How is ovarian tissue cryopreservation different from other treatments for pediatric cancer patients?

Ovarian tissue cryopreservation is unique because it is the only option for preserving fertility in prepubertal girls who need immediate cancer treatment. Unlike other treatments, it involves freezing ovarian tissue, which can later be transplanted or used for in vitro follicle maturation to restore fertility. ^{1 4 5 9 10}

Research Team

Zaraq Khan, M.B.B.S.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for girls from birth to 17 years old with conditions that threaten fertility, such as cancer or Turner's syndrome. They must be facing treatments like surgery, chemo, or radiation that could harm their ovaries. Girls who can't fully consent or have severe ovarian damage aren't eligible.

Inclusion Criteria

I am a girl 17 years old or younger.

Meet at least one of the following conditions: 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. Or have a medical condition or malignancy that requires removal of all or part of one or both ovaries. 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

My medical condition makes anesthesia and surgery riskier for me.

My cancer treatment is not just for comfort care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ovarian tissue cryopreservation as a fertility preservation method

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the cryopreservation procedure

6 months

Treatment Details

Interventions

• Ovarian tissue cryopreservation

Trial Overview The study offers ovarian tissue cryopreservation—an experimental procedure to save and freeze ovarian tissue—to young female patients at risk of losing reproductive potential due to medical treatments.

Participant Groups

Group I: Ovarian tissue cryopreservation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Ovarian cryopreservation for children aged 3 years or younger: A report of three cases. [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Ovarian tissue cryopreservation for prepubertal girls: indications and feasibility]. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Fertility preservation in girls. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Ovarian tissue cryopreservation for fertility preservation in 418 girls and adolescents up to 15 years of age facing highly gonadotoxic treatment. Twenty years of experience at a single center. [2020]

5. England pubmed.ncbi.nlm.nih.gov

In vitro development of secondary follicles from cryopreserved rhesus macaque ovarian tissue after slow-rate freeze or vitrification. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Cryopreservation of ovarian tissue in pediatric patients undergoing sterilizing chemotherapy. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Fertility preservation in pre-pubertal girls with cancer: the role of ovarian tissue cryopreservation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cryopreservation of Ovarian Tissue for Pediatric Fertility. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic assisted extracorporeal ovarian harvest: A novel technique to optimize ovarian tissue for cryopreservation in young females with cancer. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Ovarian tissue cryopreservation: a committee opinion. [2022]