Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02678910 |
| Other study ID # |
15-0927-F1V |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2017 |
| Est. completion date |
June 21, 2017 |
Study information
| Verified date |
December 2020 |
| Source |
University of Kentucky |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this research is to obtain ovarian tissue from female participants who will
receive therapy which is expected to result in a loss or impairment of ovarian function
and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating
a pregnancy in the future.
Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue
will be used for the participant's future use. There have been 86 pregnancies as a result of
frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function
has been restored in individuals for up to 7 years.
By doing this study, the investigators hope to learn of how to successfully freeze and thaw
ovarian tissue in a manner that permits subsequent use by patients at some point in the
future. Participation may also advance our knowledge of how to successfully mature follicles
and oocytes (eggs) that are contained in these tissues which may help others in the future.
Description:
The research procedures will be conducted at the University of Kentucky (UK) Medical Center.
Participants in the study will provide ovarian tissue cryopreservation for their own personal
use.
The duration of the study will be until the participant reaches age 41 years. Participants
will be broken out into four categories:
Participants will have surgical removal of their ovarian tissue using the methods determined
by their surgeon based on their medical/surgical diagnosis or treatment. Participants in one
of the following categories will participant in the study:
1. Participants have elected to have one or both ovaries removed for the treatment or
prevention of disease.
2. Participants who have elected to have surgery to remove all or part of one or both
ovaries for medical reasons where cryopreservation of the remaining limited portions of
normal ovarian cortex is the only option for fertility preservation at the time (except
that ovarian cortex from the ovary that contains the mass will not be cryopreserved).
3. Participants who have elected to have surgery to remove all or part of one or both
ovaries for medical reasons where cryopreservation of the remaining limited portions of
normal ovarian cortex is the only option for fertility preservation at the time but who
cannot or will not provide tissue to the research pool (except that ovarian cortex for
the ovary that contains the mass will not be cryopreserved).
4. Participants who have elected to have one or part of one ovary removed, solely for the
purpose of fertility preservation because they are not candidates for or choose not to
use more mature fertility preservation technologies.
Participants undergoing elective removal of an ovary (category C above) will undergo a
procedure called laparoscopy to remove the ovary. This surgery will be performed under
general anesthesia and one ovary will be removed in total through an instrument channel
employing standard techniques of operative laparoscopy. This surgical procedure is performed
solely for fertility preservation but will potentially be coordinated with another procedure
such as placement of a central line for future chemotherapy or laparotomy for another
purpose. Although only one ovary will be removed, both of the participant's ovaries must
appear normal for the procedure to be completed. The ovary to be removed will be chosen at
the time of surgery based on appearance and ease of removal. After the surgery is complete,
the participant will not have any further procedures except for a routine post-operative
visit. A 0.5 cm cross section from the short axis of the ovary will be provided to the
Department of Pathology for routine histological evaluation, and the remaining tissue will be
processed for cryopreservation. If pathology finds evidence of cancer in the ovarian tissue
provided at surgery, they may request that all of the participant's tissue (even tissue that
has been frozen for their use) be returned to pathology for a more detailed examination. In
this case, no tissue is available for the participant to use for fertility preservation
purposes.
b. Cryopreservation: Ovarian tissue will be cryopreserved under the protocol originally
established by the National Physicians Cooperative of the Oncofertility Consortium. The
ovarian tissue will be removed at a UK or Norton Healthcare facility and evaluated for gross
disease by a pathologist, embryologist, andrologist or a reproductive endocrinology and
infertility (REI) physician. The ovarian cortex will be dissected from the medulla and cut
into strips in culture/holding media, washed to remove blood cells, and cryopreserved.
Cryopreservation will be performed using modifications of the techniques described by Gosden
et al. (1994) or will be vitrified using a modification of the techniques of Kuwayama et al.,
2007. The procedure for cryopreservation/vitrification may be modified as improvements become
available.
The designated laboratory directors at UK responsible for the overall quality of the ovarian
tissue cryopreservation.
c. Tissue storage: Cryopreserved participant tissues will be transferred to Reprotech, Ltd
(RTL) in Roseville, Minnesota for storage and subsequent release. Reprotech, Ltd. is an FDA
compliant and American Association of Tissue Banks accredited long term storage facility for
reproductive tissues. Based on the extended periods of time that these tissues are likely to
be stored Reprotech, Ltd. provides maximum flexibility for the participants involved. In this
way, the participant can store tissues as long as they wish and ship them to a fertility
treatment center of their choice at the time of use. The participant can determine how her
own tissue will be used as technology changes and based on her unique circumstances.
Reprotech, Ltd. does not perform fertility treatments and is not affiliated with any
fertility center so there is no potential conflict of interest.
d. Infectious Disease Screening and Testing: Banking and subsequent use of ovarian tissue is
regulated by the Food and Drug Administration (FDA). In order to comply with current tissue
banking regulations and to be prepared for any future changes in regulations while these
ovarian tissues are in storage, participants will be tested and screened for a number of
infectious diseases prior to banking ovarian tissue.The testing will include but not be
limited to testing for Hepatitis B and C and HIV. The testing that will be performed will be
testing that is mandated for donors of leukocyte rich tissues and must be performed within 7
days of tissue procurement. In this way, the tissue could potentially be used by the
participant herself and it could also be suitable for use in another individual (such as a
surrogate) in the future if indicated by the participant's medical diagnosis.
If the ovarian tissue was vaginally removed during surgery the sites will also collect a
vaginal swab from the participant for Gonorrhea and Chlamydia testing.
Please note that if the HIV screening test is positive, a confirmatory test will then be
performed. Should the screening tests detect that participants are infected with HIV this
information will be communicated confidentially to them through personal contact by a
qualified professional. Participants will meet with a qualified professional who will provide
HIV counseling.
There are risks associated with this study and those risks are outlined in the study informed
consent document.
Benefit vs. Risk: There is no guarantee that participants will get any benefit from taking
part in this study, although 86 babies have been born from transplanted frozen ovarian
tissue. A females participation may provide her with a means to restore her fertility and
reproductive hormonal function in the future as observed in previous reports. A females
participation may also advance the investigator's understanding of how to successfully freeze
and thaw ovarian tissue in a manner that permits subsequent use by the participant and other
patients at some point in the future. A females participation may also advance the
investigator's knowledge of how to successfully mature follicles and oocytes (eggs) that are
contained in these tissues which may help the participant or others in the future. However,
there is a significant possibility that there may be no direct benefit to the participant
from her participation in this research study. Specifically, there is the possibility that
ovarian cryopreservation will not result in successful pregnancy in the future.
There are alternatives to taking part in this study and those alternatives are addressed in
the study informed consent document.
Costs: All expenses related to the research procedure will be covered by the research funds
and include the oophorectomy, anesthesia, pathologist's fees and infectious disease testing.
Either the participant or their insurance company, Medicare or Medicaid will be responsible
for the costs of all care and treatment that the participant would receive during this study
that she would normally receive for her condition. These are costs that are considered
medically reasonable and necessary and will be part of the care she receives if she does not
take part in this study. This includes the confirmatory HIV testing and the follicle
stimulating hormone (FSH) testing.
There are also costs associated with the handling, processing, shipping and storage of
ovarian tissue. Those costs are outlined in the study informed consent document.
In the unlikely event that the participant is hurt or injured while participating in this
study the medical costs related to their care and treatment will be their responsibility or
submitted to their insurance.
