Gonadal Tissue Cryopreservation for Fertility Preservation

Overseen By Kristine Corkum, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method to preserve fertility in individuals with disorders of sex development (DSD). These conditions can increase the risk of cancer and future fertility issues. The trial examines whether freezing and storing gonadal tissue (which produces eggs or sperm) is safe and effective for preserving fertility or aiding hormone balance. It is suitable for individuals under 30 with DSD who face cancer risks or early menopause due to their condition and require gonad removal for medical reasons. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could enhance future fertility preservation options.

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 prior data suggests that gonadal tissue cryopreservation is safe for fertility preservation?

Research has shown that freezing gonadal tissue is generally safe. Studies have found that procedures to freeze ovarian and testicular tissue occur without complications or significant blood loss, indicating they are well-tolerated. While researchers continue to study the success of freezing testicular tissue, freezing ovarian tissue has successfully restored function and even resulted in live births in some cases. This method also aids young patients who require treatments that might harm their reproductive organs. Animal studies support the safety of using frozen and thawed testicular tissues to restore fertility in the future. Overall, current evidence suggests this method is promising and safe for preserving fertility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cryopreservation of gonadal tissue because it offers a promising way to preserve fertility for individuals who need gonadectomies, often due to cancer treatments or other medical conditions. Unlike standard options like sperm or egg banking, this method involves freezing and storing actual gonadal tissue, which could later be re-implanted to restore fertility. This approach is particularly beneficial for prepubertal patients or those who cannot produce mature eggs or sperm. By preserving tissue that contains immature reproductive cells, this method extends fertility preservation possibilities beyond what’s currently available.

What evidence suggests that gonadal tissue cryopreservation is effective for fertility preservation in patients with gonadal dysgenesis?

Research has shown that freezing and storing reproductive tissue is a promising way to preserve fertility. Studies have found successful births after ovarian tissue was frozen and then reimplanted. This trial will involve the cryopreservation of gonadal tissue, primarily for individuals at risk of early menopause or those requiring treatments that could harm fertility. Although still considered experimental, this method offers hope for restoring fertility and hormone balance. While information on safety and reproductive outcomes remains limited, the findings are encouraging. ^{4 6 7 8 9}

Who Is on the Research Team?

Kristine Corkum, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Pregnancy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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) 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]

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]

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]

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) 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5715865/

Fertility preservation through gonadal cryopreservation Gonadal cryopreservation is yet another means for fertility preservation, especially if the gonadal function is threatened by premature menopause.

2. sciencedirect.com sciencedirect.com/science/article/pii/S266633412500011X

Gonadal tissue preservation technologies and culture offer ... Gonadal tissue preservation has emerged as a promising alternative mainly for the creation of wildlife biobanks and the restoration of fertility in humans.

3. academic.oup.com academic.oup.com/hropen/article/2017/1/hox001/3092402

Ovarian tissue cryopreservation for fertility preservation Small case series have reported successful live births after ovarian tissue cryopreservation and orthotopic transplantation, ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.70080

To improve outcome after ovarian tissue cryopreservation and ... Ovarian tissue cryopreservation (OTC) has been developed to preserve fertility for women with planned gonadotoxic treatment. It has the ...

5. asrm.org asrm.org/practice-guidance/practice-committee-documents/fertility-preservation-in-patients-undergoing-gonadotoxic-therapy-or-gonadectomy-a-committee-opinion-2019/

Fertility preservation in patients undergoing gonadotoxic ... Overall, data on the efficacy, safety, and reproductive outcomes after ovarian tissue cryopreservation are still limited. Given the current body of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3553347/

Evaluation of ovarian and testicular tissue cryopreservation ... While there are no reports of success with testicular tissue freezing, several recent studies have shown restoration of ovarian function, and/or live births ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1472648312600145

Gonadal tissue cryopreservation and transplantation It is now being considered as a potential strategy for preserving fertility in young patients, including children, undergoing sterilizing treatment for cancer ...

8. fertstertreports.org fertstertreports.org/article/S2666-3341(25)00011-X/fulltext

Gonadal tissue preservation technologies and culture offer ... Gonadal tissue preservation has emerged as a promising alternative mainly for the creation of wildlife biobanks and the restoration of fertility in humans.

9. fertstert.org fertstert.org/article/S0015-0282(12)00866-7/fulltext

Evaluation of ovarian and testicular tissue cryopreservation ... All procedures were successfully completed without complications or significant blood loss. Conclusion. Pediatric gonadal tissue cryopreservation is a safe ...