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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore ovarian tissue cryopreservation, a technique to preserve fertility for young girls undergoing medical treatments or facing conditions that might impair future childbearing ability. Although experimental, this method has resulted in the birth of over 120 babies worldwide. Suitable candidates include girls under 18 with conditions like Turner's syndrome or those requiring treatments such as chemotherapy that could impact reproductive health. Participants must consent to the procedure and allow the sharing of their health information. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could help preserve fertility for future generations.

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 prior data suggests that ovarian tissue cryopreservation is safe for pediatric cancer patients?

Research has shown that ovarian tissue freezing, a method to preserve fertility, is generally safe but still considered experimental. Studies have reported over 120 live births worldwide from this technique, indicating its potential effectiveness. One study found a 26% chance of having a baby after the procedure. While these results are encouraging, it is important to continue learning about all the safety aspects.

Some studies have shown that about 50.7% of cancer survivors successfully retrieve and preserve their ovarian tissue. However, there is a risk that about 24.3% of patients may experience premature ovarian insufficiency, where the ovaries stop functioning properly. This risk should be considered alongside the potential benefits. Overall, while the procedure shows promise, it remains experimental, and patients should carefully weigh the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard fertility preservation options like egg or embryo freezing, which aren't viable for young children, ovarian tissue cryopreservation offers a unique solution for pediatric cancer patients. This technique involves freezing ovarian tissue before cancer treatment, allowing it to be re-implanted later to restore fertility. Researchers are excited because, despite being considered experimental, this method has successfully led to over 120 live births worldwide, offering hope to children who face fertility-threatening cancer treatments.

What evidence suggests that ovarian tissue cryopreservation is effective for preserving fertility in pediatric cancer patients?

Research has shown that freezing ovarian tissue is a promising method to preserve fertility in young cancer patients. More than 120 babies have been born worldwide using this technique, demonstrating its effectiveness. This method is crucial for young girls who cannot use other options like freezing eggs. Studies highlight potential benefits for children and teenagers with cancer, offering hope for those whose treatments might impact their future ability to have children. Although still considered experimental, this procedure is increasingly viewed as a practical option for preserving fertility. ^{1 4 6 7 8}

Who Is on the Research Team?

Zaraq Khan, M.B.B.S.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

My medical condition makes anesthesia and surgery riskier for me.

My cancer treatment is not just for comfort care.

Girls with psychological, psychiatric, or other conditions which prevent giving fully informed consent

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3306942/

Cryopreservation of Ovarian Tissue in Pediatric Patients Ovarian tissue cryopreservation offers great promise for fertility preservation among young patients affected by cancer and represents the only option for ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346824000976

Female Fertility Cryopreservation Outcomes in Childhood ... This systematic review offers insight(s) into ovarian tissue cryopreservation's potential advantages for pediatric and adolescent cancer patients.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3095100/

New Advances in Fertility Preservation for Pediatric Cancer ... Overall, embryo and oocyte cryopreservation have been successful, although embryo cryopreservation currently has a higher success rate. Unfortunately, neither ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35108

Fertility preservation before and after cancer treatment in ... Medically, there is greater attrition with oocytes on thaw (80%–90% survival) compared to embryos, and live birth rates are not well- ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-02782

Fertility Preservation in People With Cancer One retrospective analysis of 97 survivors of cancer found a successful retrieval and cryopreservation rate of 50.7% in patients with ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39173181/

Utility and Outcomes of Ovarian Tissue Cryopreservation and ... Our results suggest that ovarian tissue cryopreservation and autologous transplantation are feasible options for preserving ovarian function in women with ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1083318824003413

Ovarian Tissue Cryopreservation in Pediatric Centers ... In the largest series to date of outcomes after transplantation of cryopreserved ovarian tissue from 5 European centers, the live birth rate was 26%.7 It is ...

8. academic.oup.com academic.oup.com/humrep/article/38/6/1076/7100840

Long-term follow-up to assess criteria for ovarian tissue ... The results of this review demonstrate an increased lifetime risk of POI in the cohort offered OTC, with an overall prevalence of 24.3% compared ...