CancerNCT01993732
Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function
A study testing Retrieval and Cryopreservation in people with Cancer and Effects of Chemotherapy, run by Medical College of Wisconsin at 2 sites in United States.
Trial summary
The purpose of this study is to retrieve and cryopreserve ovarian tissue from females undergoing a treatment that may lead to irreversible loss of ovarian function. Read more about this study
- Who is it for?
- Ages 3 years and older, women only
- Conditions the study is for
- Cancer, Effects of Chemotherapy, Unspecified Complication of Bone Marrow Transplant
- What is being tested?
- Retrieval and Cryopreservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2013to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must be female.
- Patient must have a disease process where the disease or its treatment adversely affects ovarian function.
- Patient must be recommended for this study by their oncologist or specialist.
- Patient (or legally authorized representative) must sign an informed consent.
Who cannot join
- Patients cannot be male.
- Patients must not be HIV positive.
- Patient cannot have a poor diagnosis such that she is not expected to survive to adulthood.
- Patient cannot have any medical condition that would contraindicate surgery.
- Patient cannot have any medical condition that would contraindicate general anesthesia.
- Patient cannot have any medical condition that would contraindicate pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Ovarian Tissue Cryopreservation As A Means Of Preserving Ovarian Function in Females Undergoing Therapeutic Procedures That Will Potentially Lead To The Irreversible Loss of Ovarian Function
The purpose of this study is to retrieve and cryopreserve ovarian tissue from females undergoing a treatment that may lead to irreversible loss of ovarian function.
Read the detailed description
The aim of this preliminary study is to retrieve and properly cryopreserve ovarian tissue for autotransplantation in any premenopausal female whose ovarian function is threatened in a physiological, pathological or iatrogenic manner in an effort to observe the return of ovarian endocrine function and development of egg(s) appropriate for use in in vitro fertilization.
- Conditions
- Cancer, Effects of Chemotherapy, Unspecified Complication of Bone Marrow Transplant, Auto Immune Disease
- Being tested
- Retrieval and Cryopreservation
- Keywords
- Cancer, Cryopreservation, Ovarian Function, In Vitro
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrieval and CryopreservationProcedure or surgery
Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.
| Study group | Role | What they receive |
|---|---|---|
| Retrieval and Cryopreservation | Experimental | Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed. Receives: Procedure: Retrieval and Cryopreservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of hormones produced by the ovarian tissue
Measured: 3 months after re-implantation
Secondary outcomes (1)
Development of egg(s) appropriate for use in in vitro fertilization
Measured: Participants will be followed through their reproductive years (until the patient reaches 45 years of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start6 Aug 2013
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
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 Medical College of WisconsinThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estil Strawn, Medical College of Wisconsin
- Investigators
- Estil Strawn, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993732
- Sponsor's protocol ID
- 126204
- Status last verified
- Aug 2019
- First submitted
- 18 Sep 2013
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tissue Cryopreservation As A Means Of Preserving Ovarian Function in Females Undergoing Therapeutic Procedures That Will Potentially Lead To The Irreversible Loss of Ovarian Function
- ClinicalTrials.gov ID
- NCT01993732
- Acronym / sponsor ID
- 126204
- Conditions
- Cancer, Effects of Chemotherapy, Unspecified Complication of Bone Marrow Transplant, Auto Immune Disease
- Keywords
- Cancer, Cryopreservation, Ovarian Function, In Vitro
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 6 Aug 2013 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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 purpose of this study is to retrieve and cryopreserve ovarian tissue from females undergoing a treatment that may lead to irreversible loss of ovarian function.
Detailed description
The aim of this preliminary study is to retrieve and properly cryopreserve ovarian tissue for autotransplantation in any premenopausal female whose ovarian function is threatened in a physiological, pathological or iatrogenic manner in an effort to observe the return of ovarian endocrine function and development of egg(s) appropriate for use in in vitro fertilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrieval and Cryopreservation | Experimental | Procedure: Retrieval and CryopreservationFemales undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed. |
Who may qualify
- Ages
- 3 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be female.
- Patient must have a disease process where the disease or its treatment adversely affects ovarian function.
- Patient must be recommended for this study by their oncologist or specialist.
- Patient (or legally authorized representative) must sign an informed consent.
Key exclusion criteria (6 listed)
- Patients cannot be male.
- Patients must not be HIV positive.
- Patient cannot have a poor diagnosis such that she is not expected to survive to adulthood.
- Patient cannot have any medical condition that would contraindicate surgery.
- Patient cannot have any medical condition that would contraindicate general anesthesia.
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 |
|---|---|---|
| Retrieval and CryopreservationFemales undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed. | Procedure or surgery | Retrieval and Cryopreservation |
Primary outcome
Return of hormones produced by the ovarian tissue
Time frame: 3 months after re-implantation
1 secondary outcome
Development of egg(s) appropriate for use in in vitro fertilization
Time frame: Participants will be followed through their reproductive years (until the patient reaches 45 years of age)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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. This study is not recruiting at the moment.
Estil Strawn, MD principal investigator
Medical College of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrieval and Cryopreservation in people with Cancer and Effects of Chemotherapy, run by Medical College of Wisconsin at 2 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of hormones produced by the ovarian tissue (time frame: 3 months after re-implantation). 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 14 Aug 2019.