Improving fertility preservation counseling by gynaecologists by providing more insight in important ascpects for patients regarding fertility preservation trough autotransplantation of cryopreserved ovarian tissue.
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome of the focus group with the aspects women find important in regard to
fertility counselling after previous fertility preservation and
autotransplantation of cryopreserved ovarian tissue.
Secondary outcome
NA
Background summary
There is an increase in long term survival rate for many cancer types [1, 2]
because of the continuing improvement of anti-cancer therapies and early
detection. However, many of these treatments (chemotherapy and/or radiation)
may cause partial or even complete and irreversible loss of fertility. Several
treatments have been developed to preserve fertility during anti-cancer
treatments. The options currently available are surgical transposition of the
ovaries outside the field of radiation, cryopreservation of oocytes or embryos
and ovarian tissue cryopreservation (OTC). Only two of these options (surgical
transposition and OTC) are available for prepubertal females as
cryopreservation of oocytes or embryos require (multiple rounds of) hormonal
stimulation and cannot be performed in this group of young patients. In our
research we will focus on OTC. Ovarian cortex strips can be cryopreserved prior
to gonadotoxic anti-cancer treatment and auto-transplanted when the patient has
been cured but experiences infertility and wishes to conceive. OTC has shown to
be a successful method for fertility preservation with a pregnancy rate of 23
up to 77% [6-8] and has thus far led to the live birth of over 130 children.
[9] The main risk of auto-transplantation of ovarian cortex strips is the
reintroduction of malignant cells that may be present in the graft. [3-5]
Malignant cells in ovarian cortex tissue are able to survive the freeze/thaw
procedure and are able to metastasize to the host after transplantation of the
tissue. Especially those with the a blood-borne nature of the malignant cells
have an increased risk of relapse after auto-transplantation. [10, 11]
Information on the relapse risk is still scarce. Because of the unknown risk on
relapse it is difficult for clinicians to determine for which patient the risk
on relapse is considered too high for autotransplantation.
There is not yet a consensus among clinicians what an acceptable risk on
relapse is after autotransplantation to strive for a pregnancy. To even begin
achieving a consensus we have to know what patients and clinicians consider
important and what are acceptable risks in pursuing a pregnancy.
Implementation of new techniques for auto-transplantation of ovarian tissue has
been primarily healthcare provider-driven. While focussing on improving safety
for this procedure however, the patient herself as a crucial stakeholder should
not been left out. Despite the increasing survival rate and thus rising desire
to regain fertility, studies concerning patients* views are none existent.
1. Brenner H, Arndt V. Recent increase in cancer survival according to age:
higher survival in all age groups, but widening age gradient. Cancer Causes
Control. 2004;15(9):903-10. doi:10.1007/s10552-004-1484-3.
2. Quaresma M, Coleman MP, Rachet B. 40-year trends in an index of survival for
all cancers combined and survival adjusted for age and sex for each cancer in
England and Wales, 1971-2011: a population-based study. Lancet.
2015;385(9974):1206-18. doi:10.1016/s0140-6736(14)61396-9.
3. Bastings L, Beerendonk CC, Westphal JR, Massuger LF, Kaal SE, van Leeuwen FE
et al. Autotransplantation of cryopreserved ovarian tissue in cancer survivors
and the risk of reintroducing malignancy: a systematic review. Human
reproduction update. 2013;19(5):483-506. doi:10.1093/humupd/dmt020.
4. Dolmans MM, Luyckx V, Donnez J, Andersen CY, Greve T. Risk of transferring
malignant cells with transplanted frozen-thawed ovarian tissue. Fertility and
sterility. 2013;99(6):1514-22. doi:10.1016/j.fertnstert.2013.03.027.
5. Rosendahl M, Schmidt KT, Ernst E, Rasmussen PE, Loft A, Byskov AG et al.
Cryopreservation of ovarian tissue for a decade in Denmark: a view of the
technique. Reproductive biomedicine online. 2011;22(2):162-71.
doi:10.1016/j.rbmo.2010.10.015.
6. Jadoul P, Guilmain A, Squifflet J, Luyckx M, Votino R, Wyns C et al.
Efficacy of ovarian tissue cryopreservation for fertility preservation: lessons
learned from 545 cases. Human reproduction (Oxford, England).
2017;32(5):1046-54. doi:10.1093/humrep/dex040.
7. Ladanyi C, Mor A, Christianson MS, Dhillon N, Segars JH. Recent advances in
the field of ovarian tissue cryopreservation and opportunities for research.
Journal of assisted reproduction and genetics. 2017;34(6):709-22.
doi:10.1007/s10815-017-0899-1.
8. Silber SJ, DeRosa M, Goldsmith S, Fan Y, Castleman L, Melnick J.
Cryopreservation and transplantation of ovarian tissue: results from one center
in the USA. Journal of assisted reproduction and genetics. 2018;35(12):2205-13.
doi:10.1007/s10815-018-1315-1.
9. Donnez J, Dolmans MM. Fertility Preservation in Women. The New England
journal of medicine. 2017;377(17):1657-65. doi:10.1056/NEJMra1614676.
10. Dolmans MM. Safety of ovarian autotransplantation. Blood.
2012;120(22):4275-6. doi:10.1182/blood-2012-07-439539.
11. Dolmans MM, Jadoul P, Gilliaux S, Amorim CA, Luyckx V, Squifflet J et al. A
review of 15 years of ovarian tissue bank activities. Journal of assisted
reproduction and genetics. 2013;30(3):305-14. doi:10.1007/s10815-013-9952-x.
Study objective
Improving fertility preservation counseling by gynaecologists by providing more
insight in important ascpects for patients regarding fertility preservation
trough autotransplantation of cryopreserved ovarian tissue.
Study design
Focus groups will be conducted with at least 5 patients per focus group who
have ovarian tissue, oocytes or embryo*s cryopreserved as fertility
preservation before start of their oncologic treatment. Eligible patients for
the focus groups receive a patient information letter, an informed consent form
and a reply card by mail on which they can indicate if they wish to participate
or do not wish to participate. A reminder is sent after 4 weeks if we do not
receive an informed consent or a reply card.
Study burden and risks
Participating in focus group: 45 minutes
Risks: Possibly confronting questions
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or older
- Cryopreserved ovarian tissue, oocytes or embryo*s for oncological reasons at
Erasmus MC, LUMC or Radboudumc
Exclusion criteria
- Severely diseased women
- Currently treated for malignancy
- Psychological problems
- Age below 18 years
- Deceased
- No knowledge of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL74349.091.20 |