Gonadal Tissue Cryopreservation for Fertility Preservation

Recruiting in Palo Alto (17 mi)

Overseen by Leslie Appiah, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

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

No Placebo Group

Approved in 2 Jurisdictions

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.

Trial 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 (Other)

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Colorado Aurora, CO

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1842

Patients Recruited

3,028,000+

Findings from 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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]