Ovarian Tissue Cryopreservation for Female Infertility

(OTC Trial)

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Phoenix Children's Hospital

Disqualifiers: Pregnancy, Breastfeeding, High surgical risk, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen

Will I have to stop taking my current medications?

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 Female Infertility?

Research shows that cryopreservation of ovarian tissue is an effective method for preserving fertility, especially for women undergoing treatments like chemotherapy that can harm the ovaries. Studies indicate that this method can help restore fertility by preserving and later using ovarian tissue, which can be crucial for women with cancer or those wanting to delay pregnancy. ^{1 2 3 4 5}

Is ovarian tissue cryopreservation safe for humans?

Ovarian tissue cryopreservation has been used for over two decades, and thousands of women worldwide have undergone the procedure, mainly to preserve fertility before treatments that could harm the ovaries. The procedure is generally considered safe, with nearly all patients who have had their tissue transplanted regaining ovarian function. ^{6 7 8 9 10}

How is ovarian tissue cryopreservation different from other treatments for female infertility?

Ovarian tissue cryopreservation is unique because it involves freezing and storing ovarian tissue, which can later be thawed and transplanted back to restore fertility. This method is particularly useful for women undergoing treatments like chemotherapy that may harm their ovaries, and it offers an option for those who wish to delay pregnancy for social reasons. ^{3 5 11 12 13}

Research Team

Eligibility Criteria

This trial is for girls who may lose their fertility due to medical treatments like high-dose chemotherapy or pelvic irradiation, and those needing ovary removal due to health conditions. They must be healthy enough for laparoscopic surgery as determined by an anesthesiologist.

Inclusion Criteria

My treatment plan includes high-dose chemotherapy or a bone marrow transplant.

My cancer treatment includes whole abdomen, pelvic, or total body irradiation.

I need surgery to remove one or both ovaries and am healthy enough for surgery.

Exclusion Criteria

Patients who are eligible for and agree to oocyte preservation

Pregnancy or a patient who is currently breastfeeding

Anyone unable to provide consent due to psychiatric conditions or cognitive delay (in parent/guardian for patients under 18 years, and patient over 18 years)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Tissue Cryopreservation

Participants undergo ovarian tissue cryopreservation for fertility preservation

2-3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after ovarian tissue cryopreservation

10 years

Treatment Details

Interventions

• Ovarian Tissue Cryopreservation (Procedure)

Trial Overview The study involves the laparoscopic removal of ovarian tissue before starting a treatment that could cause infertility. The removed tissue is then frozen for potential future use in restoring fertility.

Participant Groups

Group I: girls facing possible infertility Experimental Treatment 1 Intervention

Newly diagnosed female or relapsed malignancy who is 1-25 years of age with proposed treatment regimen containing at least ONE (1) of the following: whole abdomen or pelvic irradiation total body irradiation Proposed treatment regimen to include any of the following: cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2 any treatment regimen containing procarbazine bone marrow transplant conditioning regimen containing alkylator OR health condition or malignancy that requires removal of one or both ovaries

Who Is Running the Clinical Trial?

Phoenix Children's Hospital

Lead Sponsor

Trials

78

Recruited

5,014,000+

Robert L. Meyer

Phoenix Children's Hospital

Chief Executive Officer since 2003

Bachelor of Business Administration from the University of Michigan

Blake Bulloch

Phoenix Children's Hospital

Chief Medical Officer since 2024

MD, MBA

Findings from Research

The study found that adding vanadium to the vitrification medium significantly improved the number of healthy-looking follicles in cryopreserved mouse ovaries, indicating better preservation during freezing.

Follicles from ovaries treated with 100 μM vanadium showed higher growth and viability rates compared to those without vanadium, suggesting that vanadium enhances the effectiveness of ovarian cryopreservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation of Vitrification Medium with Vanadium: Evaluation of Histological Change and Follicle Growth. [2019]

In a study involving 24 nude mice implanted with human ovarian tissues, treatment with Setarud significantly increased vascular density in the transplanted ovarian tissue by day 7 post-transplantation, suggesting enhanced angiogenesis.

Setarud treatment resulted in lower levels of Angiopoietin-1 and higher levels of Angiopoietin-2 and Vascular Endothelial Growth Factor, indicating a potential mechanism for its angiogenic effects in preserving ovarian tissue after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Setarud (IMOD(TM)) on angiogenesis in transplanted human ovarian tissue to nude mice. Hormozi, M., Talebi, S., Khorram Khorshid, HR., et al.[2022]

This study demonstrated that immature oocytes can be successfully retrieved from ovarian tissue with minimal preparation before being sent to a cryobank, allowing for effective fertility preservation in women undergoing gonadotoxic therapies.

Out of 12 patients, the maturation rate of the retrieved oocytes was 38.9%, and fertilization rates were promising, indicating that this method can increase the number of viable oocytes available for future fertility treatments without the need for controlled ovarian stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro maturation of immature oocytes from ovarian tissue prior to shipment to a cryobank. Dietrich, JE., Jauckus, J., Hoffmann, S., et al.[2020]

Ovarian tissue cryopreservation is an effective fertility preservation method, particularly for pre-pubertal patients and those with limited time before gonadotoxic treatment, but over 90% of patients experienced reduced ovarian reserve, with 30% developing premature ovarian failure within 5 years.

Despite the risks, including one severe adverse event during anesthesia, the procedure led to successful fertility outcomes, with 33 spontaneous pregnancies and 34 live births reported among post-pubertal patients, indicating its potential as a viable option for young patients facing fertility threats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and usefulness of cryopreservation of ovarian tissue to preserve fertility: a 12-year retrospective analysis. Imbert, R., Moffa, F., Tsepelidis, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Supplementation of Vitrification Medium with Vanadium: Evaluation of Histological Change and Follicle Growth. [2019]

2. Iran pubmed.ncbi.nlm.nih.gov

The effect of Setarud (IMOD(TM)) on angiogenesis in transplanted human ovarian tissue to nude mice. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Survival of primordial follicles following prolonged transportation of ovarian tissue prior to cryopreservation. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

In vitro maturation of immature oocytes from ovarian tissue prior to shipment to a cryobank. [2020]

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

Cryopreservation and Thawing of Human Ovarian Cortex Tissue Slices. [2021]

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

Safety and usefulness of cryopreservation of ovarian tissue to preserve fertility: a 12-year retrospective analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

FERTILITY PRESERVATION: Freezing of ovarian tissue and clinical opportunities. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Delaying Reproductive Aging by Ovarian Tissue Cryopreservation and Transplantation: Is it Prime Time? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Supplementation of transport and freezing media with anti-apoptotic drugs improves ovarian cortex survival. [2018]

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

Oocyte and embryo cryopreservation before gonadotoxic treatments: Principles of safe ovarian stimulation, a systematic review. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Cryopreservation of ovarian tissue. Potential "reproductive insurance" for women at risk of early ovarian failure. [2007]

12. England pubmed.ncbi.nlm.nih.gov

Isolation of pre-antral follicles from human ovarian medulla tissue. [2013]

13. England pubmed.ncbi.nlm.nih.gov

Two successful pregnancies following autotransplantation of frozen/thawed ovarian tissue. [2022]