Gonadal Tissue Cryopreservation for Fertility Preservation
Palo Alto (17 mi)Overseen byLeslie Appiah, MD
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Colorado, Denver
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.
What safety data is available for gonadal tissue cryopreservation?The available research primarily focuses on ovarian tissue cryopreservation (OTC) as a method of fertility preservation. Studies indicate that OTC is an emerging and promising technique for preserving fertility in women and young patients undergoing gonadotoxic treatments. It has been clinically applied for almost 30 years, with some research analyzing its effectiveness, feasibility, and outcomes in various populations, including pediatric patients and those with non-malignant conditions. However, specific safety data and long-term outcomes are not extensively detailed in the provided abstracts.34678
What data supports the idea that Gonadal Tissue Cryopreservation for Fertility Preservation is an effective treatment?The available research shows that Gonadal Tissue Cryopreservation, particularly Ovarian Tissue Cryopreservation (OTC), has led to successful pregnancies and live births. For example, one study reported two live births following the transplantation of preserved ovarian tissue. Additionally, the research highlights that OTC is promising for patients undergoing treatments that could harm fertility, like chemotherapy. It has been used successfully for almost 30 years, and while data is limited for non-cancer patients, the treatment has shown positive outcomes in preserving fertility. Compared to other methods, such as hormonal stimulation or IVF, OTC offers a viable option for those who cannot use these alternatives.23458
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is cryopreservation of gonadal tissue a promising treatment for fertility preservation?Yes, cryopreservation of gonadal tissue is a promising treatment for fertility preservation. It helps people who might lose their ability to have children due to treatments like chemotherapy. This method has led to successful pregnancies and births, and it offers hope for both women and men who want to preserve their fertility for the future.12345
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
I am over 18 and capable of giving my own consent.
My child is between 7-17 years old and cannot give consent due to mental health or cognitive issues.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Cryopreservation of gonadal tissueExperimental Treatment1 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 nearbySelect from list below to view details:
University of ColoradoAurora, CO
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
References
Survival of primordial follicles following prolonged transportation of ovarian tissue prior to cryopreservation. [2022]Cryopreservation of ovarian tissue for fertility preservation is becoming increasingly common. Treatment of diseases that may deprive the ovaries of follicles is often performed at local hospitals that are without the necessary facilities and expertise to cryopreserve ovarian tissue. The aim of the present study was to evaluate whether primordial follicles of ovarian cortex survive transport for up to 4 h prior to cryopreservation.
The future potential of cryopreservation for assisted reproduction. [2023]Cryopreservation of human gonadal tissue and oocytes has brought about new and exciting research in reproductive medicine, as well as new cryopreservation techniques that are dramatically improving post-thaw viability and freezing damage. The work done on gonadal tissues is aimed at improving the quality of life for infertile patients and for prepubertal patients undergoing gonadotoxic chemotherapy, patients for whom hormonal stimulation/IVF is not an option, and women without partners. Cryopreservation of mature oocytes is the best model for timing IVF. Vitrification is likely to benefit the field, and since 2005, implantation and pregnancy rates from vitrified oocytes have matched or eclipsed results from conventional methods, due to new cell-specific methods and formulas. Cryopreservation of immature oocytes leads to a new direction of egg banking in future. Preserving ovarian tissue for autografting is still promising and has resulted in folliculogenesis, resumed hormone production and live births in limited cases. The use of small cortical blocks, or mechanical/chemical digestion of ovarian tissue for isolation of follicles is a new direction for ovary preservation for reasons of cryoprotectant permeation and graft revascularization. Maturation of follicles in vitro has become more feasible with the use of alginate microencapsulation. Testicular tissue preservation has taken a sharp turn towards preservation of gonadal stem cells. Research into the mechanism for spermatogenesis points to the ability for male germ cells to resume spermatogenesis. The cryopreservation of minced testicular tissue for isolation of germ cells via chemical digestion has produced viable cells, however, structural damage that may be avoided by vitrification has been noted to the surrounding cell junctions and supporting cells.
[Cryoconservation of ovarian tissue: indications and outcome of the patients]. [2014]Ovarian Tissue Cryopreservation (OTC) is a very promising approach of fertility preservation for women and young patients who have to follow gonadotoxic treatments (chemotherapy, radiotherapy…). The aim of this study was to analyse the indications and the outcomes of the patients who had OTC in our center during the last 17 years.
Fertility preservation in pediatric female cancer patients. [2018]To describe and demonstrate ovarian tissue cryopreservation (OTC) as an emerging fertility preservation technique DESIGN: Video presentation.
Two live births following orthotopic ovarian tissue autotransplantation: A case report of cycle monitoring and (modified) natural-cycle IVF in one patient. [2022]Ovarian tissue cryopreservation (OTC) is an option to preserve fertility. This article describes the effect of cycle monitoring on the chances of pregnancy following orthotopic ovarian tissue autotransplantation.
Ovarian tissue cryopreservation in Malaysia: a case series. [2022]We aim to discuss the hematological cancer cases that opted for ovarian tissue cryopreservation (OTC) as fertility preservation before the gonadotoxic chemotherapy agent.
Analysis of Fertility Preservation by Ovarian Tissue Cryopreservation in Pediatric Children in China. [2022]Ovarian tissue cryopreservation (OTC) is the only method of fertility preservation (FP) in prepubertal girls, but the experience remains limited. This study investigates the effectiveness and feasibility of FP of OTC in children facing gonadotoxicity treatment in Chinese first ovarian tissue cryobank.
Successful pregnancy rates amongst patients undergoing ovarian tissue cryopreservation for non-malignant indications: A systematic review and meta-analysis. [2023]Ovarian tissue cryopreservation (OTC) is a fertility preservation method that has been clinically applied for almost 30 years. Studies specifically evaluating patients presenting with non-malignant indications for OTC and their subsequent pregnancy rates are limited.