Gonadal Tissue Cryopreservation for Fertility Preservation

Overseen By Jocelyn Phipers

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Retain fertility, High perioperative risk, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The "Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation" study is open to a subset of patients with disorders of sex development (DSD) which is associated with the risk of malignancy and a high risk of infertility or sterility. For these patients, experimental gonadal tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility and/or restoring hormonal function in patients with gonadal dysgenesis who are at risk of decreased fertility potential or malignancy.

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 Gonadal Tissue Cryopreservation for Fertility Preservation?

Research shows that ovarian tissue cryopreservation (OTC) has led to resumed hormone production and live births in some cases, making it a promising option for preserving fertility, especially for patients undergoing treatments that could harm their reproductive organs. ^{1 2 3 4 5}

Is gonadal tissue cryopreservation safe for humans?

Ovarian tissue cryopreservation (OTC) has been used for almost 30 years as a fertility preservation method, especially for patients undergoing treatments that can harm reproductive organs, like chemotherapy. While the research primarily focuses on its effectiveness, the long history of clinical use suggests it is generally considered safe. ^{1 2 5 6 7}

How is gonadal tissue cryopreservation different from other fertility preservation treatments?

Gonadal tissue cryopreservation is unique because it involves freezing ovarian or testicular tissue to preserve fertility, which is particularly beneficial for patients who cannot undergo hormonal stimulation or IVF, such as prepubertal patients or those undergoing gonadotoxic treatments. This method allows for the potential of future fertility by preserving tissue that can later be transplanted back to restore reproductive function. ^{2 3 4 5 8}

Research Team

Leslie Appiah, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for patients with disorders like Turner Syndrome, who face a high risk of infertility or ovarian cancer. It's open to those who have limited fertility preservation options due to their condition.

Inclusion Criteria

I am diagnosed with a sex development disorder and need my gonads removed due to cancer risk.

I am under 30 years old.

I have a genetic condition putting me at risk of early ovarian failure.

Exclusion Criteria

Patients likely to retain inherent fertility and reproductive function

I am considered at high risk for complications from surgery.

I am over 18 and capable of giving my own consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo gonadal tissue processing, freezing, and cryopreservation after standard care procedures

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after gonadal tissue cryopreservation

10 years

Treatment Details

Interventions

• Cryopreservation of gonadal tissue

Trial Overview The study tests the safety and effectiveness of freezing gonadal tissue (ovaries) to preserve fertility and possibly restore hormone function in patients at risk of infertility or cancer.

Participant Groups

Group I: Cryopreservation of gonadal tissue Experimental Treatment 1 Intervention

Enrolled participants will undergo gonadal tissue processing, freezing and cryopreservation after the standard care (gonadectomy, gonadal tissue histologic examination)

Cryopreservation of gonadal tissue is already approved in United States, European Union for the following indications:

Approved in United States as Gonadal tissue cryopreservation for:

• Experimental fertility preservation for patients with disorders of sex development (DSD)

Approved in European Union as Gonadal tissue cryopreservation for:

• Experimental fertility preservation for patients with disorders of sex development (DSD)

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

A systematic review of 16 studies found that about 23.52% of women who underwent ovarian tissue cryopreservation (OTC) for non-malignant reasons achieved a successful pregnancy, providing valuable data for fertility preservation counseling.

Successful pregnancy rates were notably higher in case series studies (47.02%) compared to cohort studies (14.64%), suggesting that study design may influence reported outcomes in OTC research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful pregnancy rates amongst patients undergoing ovarian tissue cryopreservation for non-malignant indications: A systematic review and meta-analysis. Finkelstein, T., Zhang, Y., Vollenhoven, B., et al.[2023]

Ovarian Tissue Cryopreservation (OTC) has been performed on 46 patients over 17 years, primarily for fertility preservation in young women undergoing gonadotoxic treatments, with a significant portion (52%) being minors.

After OTC, 57% of patients experienced premature ovarian failure, but 8 patients achieved pregnancies, indicating that while OTC can help preserve fertility, long-term monitoring and support are crucial for managing potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cryoconservation of ovarian tissue: indications and outcome of the patients]. Desvignes, F., Pouly, JL., Janny, L., et al.[2014]

Ovarian tissue cryopreservation (OTC) followed by orthotopic transplantation can successfully lead to pregnancy, as demonstrated in a case where a woman conceived after IVF using ovarian tissue placed in a peritoneal window.

Monitoring the ovarian cycle and using modified natural-cycle IVF (MNC IVF) can enhance the chances of conception, as evidenced by the successful pregnancies following the transplantation of ovarian tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two live births following orthotopic ovarian tissue autotransplantation: A case report of cycle monitoring and (modified) natural-cycle IVF in one patient. Klijn, NF., Louwé, LA., Pilgram, GSK., et al.[2022]

Cryopreservation techniques, particularly vitrification, have significantly improved the viability of human gonadal tissues and oocytes, leading to successful implantation and pregnancy rates that match or exceed those from conventional methods.

Research into preserving ovarian and testicular tissues is advancing, with promising results in folliculogenesis and spermatogenesis, suggesting potential for future fertility treatments, especially for patients undergoing gonadotoxic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future potential of cryopreservation for assisted reproduction. Song, Y., Sharp, R., Lu, F., et al.[2023]

Ovarian tissue cryopreservation (OTC) is a promising fertility preservation technique for young cancer patients, demonstrated through a case involving a 6-year-old girl undergoing treatment for aplastic anemia.

The procedure involves laparoscopic oophorectomy to harvest ovarian tissue, which contains immature follicles, and is recommended over ovarian decortication due to the small size of prepubertal ovaries, making it a viable option for preserving fertility before gonadotoxic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fertility preservation in pediatric female cancer patients. Arian, SE., Flyckt, RL., Herman, R., et al.[2018]

Ovarian tissue cryopreservation (OTC) is a safe and effective method for preserving fertility in prepubertal girls facing treatments that may harm their ovaries, as demonstrated in a study of 49 children aged 1 to 14.

Chemotherapy prior to OTC does not significantly affect the number of ovarian follicles retrieved, although it does lower AMH hormone levels, indicating that OTC remains a viable option even after such treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Fertility Preservation by Ovarian Tissue Cryopreservation in Pediatric Children in China. Ruan, X., Cheng, J., Du, J., et al.[2022]

Ovarian tissue cryopreservation (OTC) was successfully performed on four young women (average age 24) with hematological cancers, primarily lymphoma, to preserve fertility before undergoing chemotherapy.

All patients received GnRH analogs as a protective measure during treatment, and they are currently recovering well, suggesting that OTC is a viable fertility preservation strategy for women facing immediate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian tissue cryopreservation in Malaysia: a case series. Mat Jin, N., Ahmad, SM., Mohd Faizal, A., et al.[2022]

Transporting ovarian cortex cooled on ice for up to 4 hours before cryopreservation allows for the survival of primordial follicles, as demonstrated in a study involving four patients.

After transplantation into immunodeficient mice, surviving follicles were found in all samples, indicating that the method is effective for preserving fertility in patients undergoing treatments that may harm their ovaries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival of primordial follicles following prolonged transportation of ovarian tissue prior to cryopreservation. Schmidt, KL., Ernst, E., Byskov, AG., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Successful pregnancy rates amongst patients undergoing ovarian tissue cryopreservation for non-malignant indications: A systematic review and meta-analysis. [2023]

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

[Cryoconservation of ovarian tissue: indications and outcome of the patients]. [2014]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Two live births following orthotopic ovarian tissue autotransplantation: A case report of cycle monitoring and (modified) natural-cycle IVF in one patient. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The future potential of cryopreservation for assisted reproduction. [2023]

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

Fertility preservation in pediatric female cancer patients. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of Fertility Preservation by Ovarian Tissue Cryopreservation in Pediatric Children in China. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Ovarian tissue cryopreservation in Malaysia: a case series. [2022]

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

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