Ovarian tissue cryopreservation (OTC) was deemed standard of care by the American Society of Reproductive Medicine in the US as recently as 2019. The state of OTC at various centers has not been well-described since that time, especially in the pediatric and adolescent patient population. Additionally, the available procedures and structure of fertility preservation programs throughout the country varies widely, as do factors related to insurance coverage, state mandates for fertility preservation coverage, and overall affordability. The European experience related to OTC, has been well published in recent literature. This survey aims to collect information to describe the current state of fertility programs across the US which currently offer, desire to offer or do not offer OTC.
Please provide main institution that your fertility program covers. (Please note, institutional names will not be shared in any published results and the question is asked in order to avoid duplication with multiple respondents from one institution.)
Pediatric or adult oncology
Pediatric and adolescent gynecology
Reproductive endocrinology and infertility
General/adult obstetrics/gynecology
Pediatric or adult endocrinology
Pediatric or adult general surgery
Pediatric or adult urology
Other
What is your clinical role? (choose all that apply)
How many years have you been in practice (counting fellowship if applicable)?
1-2
3-5
6-10
10+
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming District of Columbia US Common Wealth/Territory
Academic medical center
Non-academic hospital/medical center
Private practice
Hybrid
Other
Does your state have a mandate regarding insurance coverage for infertility / fertility preservation?
Yes
No
I don't know
Does the mandate cover OTC?
In all cases
In some but not all cases
I don't know
What factors determine coverage?
Insurance coverage
Age/Pubertal status
Disease Type
Gonadotoxic Risk
Other
I do not know
Does your institution currently perform procedures for the purpose of ovarian tissue cryopreservation (OTC) as a fertility preservation option?
Yes, we have an established program
Yes, we just recently established a program (< 1 year of performing OTC)
No, not yet
Given you are a newer program, we would be interested to hear about your experience on recent barriers to beginning your program as well as information on how your program is running. Your input is valuable to us. This will likely add 2-5 minutes to your survey experience.
How many procedures for ovarian tissue cryopreservation (OTC) are performed per year at your institution?
0-5
6-10
10-20
20+
Unsure/don't know
Approximately how many procedures for OTC have been performed at your institution since your program started?
0-10
11-25
26-50
51-100
101-150
150+
Unsure/don't know
What year did your institution start offering OTC?
Does your institution currently perform OTC as standard of care (clinical, non-research) or as a research procedure under IRB protocol?
Clinical/Standard of care for all patients
Research protocol/IRB for all patients
Mixed standard of care/IRB depending on the population
Do you have an IRB for data collection only?
Yes
No
When did your institution transition away from using an IRB?
2019 or earlier
2020
2021
2022
N/A- we have never used an IRB
For which population do you require an IRB
When did your institution transition away from using an IRB for all patients?
2019 or earlier
2020
2021
2022
N/A- We have always had a mixed approach
Who provides formal fertility preservation counseling to patients with ovaries (check all that apply)?
Who provides the majority of the formal fertility preservation counseling to patients with ovaries (choose one)?
Fertility Patient Navigator
Treating oncologist
Gynecologist
Endocrinologist
Other
What is the training/background of the person completing the majority of fertility preservation counseling at your institution?
Attending physician (MD/DO)
Physician in training (MD/DO fellow or resident)
Physician assistant (PA)
Nurse Practitioner (APN or equivalent)
Nurse (RN or equivalent)
Other
What patient populations do you counsel/discuss OTC as a fertility preservation option for at your institution? (check all that apply)
For what patient populations do you actually perform OTC as a fertility preservation option at your institution? (check all that apply)
If you do not perform OTC procedure in certain populations, do you make OTC available via referral to other institutions?
If your institution does not offer OTC as an option to some of the populations above, what barriers have you identified?
In patients receiving gonadotoxic therapy, at what phase of treatment is OTC offered?
What do you use to assess risk of therapy?
Meacham LR, Burns K, Orwig KE, Levine J. Standardizing Risk Assessment for Treatment-Related Gonadal Insufficiency and Infertility in Childhood Adolescent and Young Adult Cancer: The Pediatric Initiative Network Risk Stratification System. J Adolesc Young Adult Oncol. 2020 Dec;9(6):662-666.
If you use the PIN risk stratification grid, at what level of risk are you willing to offer OTC?
How often do you recommend OTC to patients at minimally increased risk?
None
Rarely
Sometimes
Always
How often do you recommend OTC to patients at significantly increased risk
None
Rarely
Sometimes
Always
How often do you recommend OTC to patients at highly increased risk
None
Rarely
Sometimes
Always
If you utilize minimum treatment threshold to create your risk assessments, what is your minimum risk for offering OTC in the following scenarios for postpubertal patients with ovaries:
< 4
4-8
>8
Other (specify)
Pelvic/Abdominal Radiation
<10 Gy
>10 Gy
Other (specify)
All BMT patients
Myeloablative BMT
CED based threshold
If you utilize minimum treatment threshold to create your risk assessments, what is your minimum risk for offering OTC in the following scenarios for prepubertal patients with ovaries:
<8
8-12
>12
Other (specify)
Pelvic/Abdominal Radiation
<15 Gy
>15 Gy
Other (specify)
All BMT patients
Myeloablative BMT
CED based threshold
If you use other things to assess risk of therapy, please specify
How often is surgery for OTC paired with at least one other procedure?
Every time
Most of the time
Sometimes
Rarely
Never
What type of surgeon(s) is/are performing the surgery for OTC at your institution?
What proportion of OTC surgeries are being performed laparoscopically vs open?
Almost all laparoscopic (open only if concurrent with another open procedure)
Same laparoscopic and some open
Mostly open
What procedure is typically being performed to collect ovarian tissue for OTC?
Unilateral salpingo-oophorectomy (removing one complete ovary and fallopian tube)
Unilateral oophorectomy (removing one complete ovary)
Unilateral partial oophorectomy (removing a portion of one ovary)
Dependent on patient factors
Other
If you change the procedure based on patient factors, what factors influence your decision?
What instrumentation do you utilize most commonly for tissue dissection and removal?
Electrothermal biopolar device (ie: LigaSure™)
Ultrasonic system (ie: Harmonic®)
Cold techniques (cold scissors with minimal coagulation, etc)
Other
I don't know
Do you send tissue to pathology?
Yes
No
Sometimes
Not sure
If pathology is involved, how much tissue is provided to pathology?
< 5%
5-20%
20-50%
Whole ovary
N/A
I don't know
What sections of ovarian tissue are provided to pathology?
Cortex only
Cortex and medulla
Medulla only
Whole ovary
Other
N/A
I don't know
How does pathology evaluate the specimen?
Gross evaluation only (pathologic if noted concern)
Gross evaluation and pathologic analysis routinely
Dependent on diagnosis
I don't know
Other
N/A
What type of media do you use to transport the ovarian tissue?
OFC Holding media (Origio/Cooper Surgical)
Lactate Ringers
Other
Who is processing the ovarian tissue?
Pathology at home institution
REI at home institution
Local REI (not affiliated with your institution)
Compensated service at outside facility
UPMC Contracted Lab
Other institution/facility
How often do your patients obtain insurance approval for the surgical procedure for OTC?
Always
Most of the time
Sometimes
Rarely
Never
I don't know
What is the typical out of pocket cost of the surgical procedure for OTC to your patient/family with stand-alone OTC (if not covered by insurance)?
$0-1000
$1,001-5,000
$5,000-15,000
>$15,000
Unknown
NA, always covered by insurance
What is the typical out of pocket cost of surgical procedure for OTC to your patient/patient's parents with OTC when combined with another procedure (if OTC portion not covered by insurance)?
$0-1000
$1,001-5,000
$5,000-15,000
>$15,000
Unknown
NA, always covered by insurance
What is the typical storage fee for your patients (per year)?
$0
$1-250
$251-500
$501-1,000
>$1,000
Does your institution have philanthropic funds to offer for OTC?
Yes
No
None available
Not necessary, OTC covered by insurance/mandates
Who is eligible for funding?
Is philanthropic funding internal or external to your institution?
Internal
External
Mixed
N/A, no funding available
I do not know
Do you collect a portion of the ovary for research?
Yes
No
Offered/optional
I don't know
How do you utilize this tissue?
Banking at home institution for future undetermined projects
Banking at home institution for on-going project(s)
Banking at outside institution for future undetermined projects
Banking at outside institution for on-going project(s)
Other
Where do you send your tissue?
Do you collect information from OTC patients in a database?
Yes
No
What kind of data do you collect?
Is this data collected under an IRB protocol?
Yes, all
No
Mixed (Ex: IRB for research, not for QI/QA)
Would you be interested in collecting data on OTC patients if process made available and accessible?
Yes
No
Have you referred anyone for re-implantation of cryopreserved tissue?
Yes
No
Where have you referred for re-implantation?
Are you planning to (or have a strong desire to) offer Ovarian Tissue Cryopreservation (OTC) as part of your fertility preservation program?
Yes
No
What barriers have led to this decision?
Where are you in the process of offering OTC?
Unsurmountable barriers, No immediate plans to proceed at this time
Haven't started, would like to / in initial planning stages
Actively in the planning process
Planned for opening in the next 3-6 months
Do you plan to open this protocol through the IRB at your institution?
No
Yes, for all patient
Yes, for certain patient populations
Which of the following populations will be requiring an IRB?
Are you currently referring patients to another institution for OTC?
Yes
No
Where are you commonly referring?
Academic institution
Private institution
Other
Referring institution does have IRB protocol
Referring institution does not have IRB protocol
I do not know if they have an IRB protocol
Referring institution does have IRB protocol
Referring institution does not have IRB protocol
I do not know if they have an IRB protocol Unknown
If referring to other places, please specify:
How far are patient's asked to travel for OTC
<50 miles
50-200 miles
>200 miles
How many patients do you refer annual
<5
5-25
>25
Is there funding for associated patient/family costs
Yes
No
Fully funded (including travel expense)
Fully funded medical expenses (minus travel expense)
Partial funding of medical expenses
Partial funding of travel costs
Other
What barriers have you identified in starting your program (choose all that apply)?
Please, specify what other barriers you have encountered.
Please, further elaborate on the legal concerns you have encountered
What barrier would you consider the largest (most difficulty to overcome) in starting your program (Choose one)
Lack of available team members
Lack of any or adequate protected time for any of the above human resources
Lack of OR time/availability
This is not a priority to medical team/institution
Lack of funding
Lack of available surgeon for procedures
Lack of resources for processing ovaries
Do not feel comfortable determining eligibility and/or counseling patients
Lack of published guidelines/direction on how to start OTC
Issues with contracting or other legal concerns
Other
Would you be willing to be contacted for additional related surveys and/or for follow up questions in the future?
Yes
No
Email address
* must provide value