CancerNCT05875155
Ovarian Tissue Cryopreservation for Fertility Preservation
An observational study of Cancer and Autoimmune Diseases, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this observational study is to learn about fertility preservation for pre-pubertal, peri-pubertal, and adult participants that are unable to pursue clinical standard of care fertility preservation such as egg (oocyte) and embryo cryopreservation. Read more about this study
- Who is it for?
- Ages Up to 39 years, women only
- Conditions the study is for
- Cancer, Autoimmune Diseases
- What is being tested?
- Infectious Disease Labwork and Fertility-Based Labwork
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2011to Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Eligible patients who will undergo an infertility-causing treatment and for whom standard of care fertility preservation procedures are not available will be identified by their physician.
Who may be able to join
- Be female age less than 40 years old.
- Unable or unwilling to make use of oocyte or embryo banking alone.
- Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent ovarian function.
- Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
- Or, Have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
- Have two ovaries if undergoing elective removal of an ovary for fertility preservation only.
Who cannot join
- Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Rachel Neelley, BA, 4126417475 ext. 1, fertilitypreservation@upmc.edu
About this study
Official title: Ovarian Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens
The goal of this observational study is to learn about fertility preservation for pre-pubertal, peri-pubertal, and adult participants that are unable to pursue clinical standard of care fertility preservation such as egg (oocyte) and embryo cryopreservation.
In addition, this study will provide research tissue for the following Specific Aims:
- To optimize techniques for cryopreservation of ovarian tissues from patients at significant risk for infertility.
- To investigate factors affecting successful maturation ovarian tissue.
Participants will undergo a surgical procedure to remove an ovary (oophorectomy) to preserve their gonadal tissue for fertility preservation.
Read the detailed description
The cure rate of cancer in children, adolescents and young adults continues to increase with advances in chemotherapy and/or radiation protocols. As more pediatric oncology patients become long-term survivors, the consequences of their treatment on their quality of life have become an important thrust of clinical oncology and basic science research. One of the most common and most devastating long-term sequelae following cancer treatment is infertility. Many chemotherapy and radiation-containing regimens for cancer therapy or prior to bone marrow transplantation can cause sterility in children and young adults. Fertility-preserving options are available for adult women (embryo freezing), but not all adult women are able to take advantage of this option since it requires fertilization. Some adult women are not able to cryopreserve embryos because they lack a partner or cannot delay treatment for the time required for ovarian stimulation. Currently, no fertility-preserving options are available for prepubescent girls who are not yet producing mature gametes and post-pubescent females whose follicular pool cannot be shielded from cancer therapy. However, experimental techniques are currently being developed to provide future alternatives for patients that preserve their ovarian tissue/cells prior to gonadotoxic treatment. In order to take advantage of these and future technologies, patients must harvest and preserve their ovarian tissue and/or oocytes (eggs) prior to the initiation of gonadotoxic therapy. This study will be available to girls and women from prepubertal years through 40 years of age who will undergo potentially sterilizing treatments. The primary objective of the proposed study is to develop techniques for long-term preservation of ovarian function through cryopreservation of ovarian tissue and/or cells prior to therapies that are likely to cause infertility (e.g., chemotherapy, radiation). This study will maintain cryopreserved ovarian tissue and/or cells for participating patients as a resource for future elective procedures to attempt fertility restoration. This study will also provide long-term follow-up on the fertility status of patients that will undergo a potentially sterilizing treatment for their primary disease or condition.
Fertility status has an important impact on the post-treatment quality of life for cancer survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow transplantation). Established fertility preserving therapies are available for adult women, but these therapies are not accessible or appropriate for all adult female patients. Currently there are no therapies to preserve the future fertility of preadolescent girls. However, new reproductive therapies are under development and may one day offer "fertile hope" to those survivors that do not currently have access to fertility preserving therapies. Clinical management of fertility-threatening diseases and treatments must have foresight of the gonadotoxic side effects and the potential for infertility. When no established fertility sparing options are available, it is reasonable to offer harvesting and cryopreservation of ovarian tissue as a possible means of fertility preservation. This study will provide a pool of research tissue that will be used to develop and test methods for manipulation and cryopreservation of ovarian tissue. Progress in these investigations may open up a range of new fertility preservation techniques to female patients that currently have no options. At the same time, a substantial portion of the patient's ovarian tissue will be cryopreserved and reserved for her own future use.
- Conditions
- Cancer, Autoimmune Diseases
- Being tested
- Infectious Disease Labwork, Fertility-Based Labwork
- Keywords
- Fertility, Fertility Preservation, Infertility, Ovary, Ovarian, Oncofertility
- Medical subject headings
- Neoplasms, Autoimmune Diseases, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infectious Disease LabworkDiagnostic test
Infectious disease labs will be drawn and resulted.
Fertility-Based LabworkDiagnostic test
Other labwork to understand fertility may be drawn.
| Study group | Role | What they receive |
|---|---|---|
| Cryopreservation | Participants will have autologous ovarian tissue cryopreserved for fertility preservation. Receives: Diagnostic Test: Infectious Disease Labwork; Diagnostic Test: Fertility-Based Labwork |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop techniques for long-term preservation of female ovarian function through cryopreservation (freezing) of ovarian tissue and/or cells prior to therapies that are likely to cause infertility (e.g., chemotherapy, radiation).
Treatment with specific chemotherapeutic agents and regimens induces prolonged absence of menstrual cycle in women of reproductive age. Sterilizing agents are thought to act directly on the ovary and produce premature ovarian insufficiency. Techniques will be developed through utilizing scientifically proven standards for long-term preservation of ovarian tissue and/or cells prior to gonadotoxic treatment.
Measured: [10 years]
Maintain cryopreserved ovarian tissue and/or cells for participating patients as a resource for future elective procedures to attempt fertility restoration.
Ovarian tissue containing immature oocytes has been successfully cryopreserved in several animal models. When thawed, this tissue can be grafted into a host with resumption of both endocrine and reproductive function. Ovarian tissue cryopreservation has the important advantage of not requiring controlled ovarian hyperstimulation, thus, eliminating the delay in cancer therapy as well as elevated estradiol levels in patients with hormone sensitive cancers. After cancer therapy, participants can utilize their frozen ovarian tissue for transplantation or other applications, as eligible.
Measured: [10 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start13 Jan 2011
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Orwig, University of Pittsburgh
- Investigators
- Kyle Orwig, PhD, Principal investigator, University of Pittsburgh/ University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875155
- Sponsor's protocol ID
- STUDY19080200
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens
- ClinicalTrials.gov ID
- NCT05875155
- Acronym / sponsor ID
- STUDY19080200
- Conditions
- Cancer, Autoimmune Diseases
- Keywords
- Fertility, Fertility Preservation, Infertility, Ovary, Ovarian, Oncofertility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 13 Jan 2011 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about fertility preservation for pre-pubertal, peri-pubertal, and adult participants that are unable to pursue clinical standard of care fertility preservation such as egg (oocyte) and embryo cryopreservation.
In addition, this study will provide research tissue for the following Specific Aims:
- To optimize techniques for cryopreservation of ovarian tissues from patients at significant risk for infertility.
- To investigate factors affecting successful maturation ovarian tissue.
Participants will undergo a surgical procedure to remove an ovary (oophorectomy) to preserve their gonadal tissue for fertility preservation.
Detailed description
The cure rate of cancer in children, adolescents and young adults continues to increase with advances in chemotherapy and/or radiation protocols. As more pediatric oncology patients become long-term survivors, the consequences of their treatment on their quality of life have become an important thrust of clinical oncology and basic science research. One of the most common and most devastating long-term sequelae following cancer treatment is infertility. Many chemotherapy and radiation-containing regimens for cancer therapy or prior to bone marrow transplantation can cause sterility in children and young adults. Fertility-preserving options are available for adult women (embryo freezing), but not all adult women are able to take advantage of this option since it requires fertilization. Some adult women are not able to cryopreserve embryos because they lack a partner or cannot delay treatment for the time required for ovarian stimulation. Currently, no fertility-preserving options are available for prepubescent girls who are not yet producing mature gametes and post-pubescent females whose follicular pool cannot be shielded from cancer therapy. However, experimental techniques are currently being developed to provide future alternatives for patients that preserve their ovarian tissue/cells prior to gonadotoxic treatment. In order to take advantage of these and future technologies, patients must harvest and preserve their ovarian tissue and/or oocytes (eggs) prior to the initiation of gonadotoxic therapy. This study will be available to girls and women from prepubertal years through 40 years of age who will undergo potentially sterilizing treatments. The primary objective of the proposed study is to develop techniques for long-term preservation of ovarian function through cryopreservation of ovarian tissue and/or cells prior to therapies that are likely to cause infertility (e.g., chemotherapy, radiation). This study will maintain cryopreserved ovarian tissue and/or cells for participating patients as a resource for future elective procedures to attempt fertility restoration. This study will also provide long-term follow-up on the fertility status of patients that will undergo a potentially sterilizing treatment for their primary disease or condition.
Fertility status has an important impact on the post-treatment quality of life for cancer survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow transplantation). Established fertility preserving therapies are available for adult women, but these therapies are not accessible or appropriate for all adult female patients. Currently there are no therapies to preserve the future fertility of preadolescent girls. However, new reproductive therapies are under development and may one day offer "fertile hope" to those survivors that do not currently have access to fertility preserving therapies. Clinical management of fertility-threatening diseases and treatments must have foresight of the gonadotoxic side effects and the potential for infertility. When no established fertility sparing options are available, it is reasonable to offer harvesting and cryopreservation of ovarian tissue as a possible means of fertility preservation. This study will provide a pool of research tissue that will be used to develop and test methods for manipulation and cryopreservation of ovarian tissue. Progress in these investigations may open up a range of new fertility preservation techniques to female patients that currently have no options. At the same time, a substantial portion of the patient's ovarian tissue will be cryopreserved and reserved for her own future use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryopreservation | – | Diagnostic Test: Infectious Disease Labwork, Diagnostic Test: Fertility-Based LabworkParticipants will have autologous ovarian tissue cryopreserved for fertility preservation. |
Who may qualify
- Ages
- Up to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Eligible patients who will undergo an infertility-causing treatment and for whom standard of care fertility preservation procedures are not available will be identified by their physician.
Key inclusion criteria (6 listed)
- Be female age less than 40 years old.
- Unable or unwilling to make use of oocyte or embryo banking alone.
- Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent ovarian function.
- Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
- Or, Have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
Key exclusion criteria (2 listed)
- Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infectious Disease LabworkInfectious disease labs will be drawn and resulted. | Diagnostic test | Cryopreservation |
| Fertility-Based LabworkOther labwork to understand fertility may be drawn. | Diagnostic test | Cryopreservation |
Primary outcome
Develop techniques for long-term preservation of female ovarian function through cryopreservation (freezing) of ovarian tissue and/or cells prior to therapies that are likely to cause infertility (e.g., chemotherapy, radiation).
Time frame: [10 years]
Treatment with specific chemotherapeutic agents and regimens induces prolonged absence of menstrual cycle in women of reproductive age. Sterilizing agents are thought to act directly on the ovary and produce premature ovarian insufficiency. Techniques will be developed through utilizing scientifically proven standards for long-term preservation of ovarian tissue and/or cells prior to gonadotoxic treatment.
Maintain cryopreserved ovarian tissue and/or cells for participating patients as a resource for future elective procedures to attempt fertility restoration.
Time frame: [10 years]
Ovarian tissue containing immature oocytes has been successfully cryopreserved in several animal models. When thawed, this tissue can be grafted into a host with resumption of both endocrine and reproductive function. Ovarian tissue cryopreservation has the important advantage of not requiring controlled ovarian hyperstimulation, thus, eliminating the delay in cancer therapy as well as elevated estradiol levels in patients with hormone sensitive cancers. After cancer therapy, participants can utilize their frozen ovarian tissue for transplantation or other applications, as eligible.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Orwig, PhD principal investigator
University of Pittsburgh/ University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Autoimmune Diseases, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Neelley, BA (4126417475 ext. 1, fertilitypreservation@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop techniques for long-term preservation of female ovarian function through cryopreservation (freezing) of ovarian tissue and/or cells prior to therapies that are likely to cause infertility (e.g., chemotherapy, radiation). (time frame: [10 years]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.