Should Ovarian Tissue Cryopreservation in Pediatric Patients with Turner Syndrome Be Limited to the Research Setting?

被引:2
作者
Mumford, Kelsey [1 ,3 ]
Hendriks, Saskia [1 ]
Gomez-Lobo, Veronica [2 ]
机构
[1] Natl Inst Hlth Clin Ctr, Dept Bioeth, Bethesda, MD USA
[2] NICHHD, Pediat & Adolescent Gynecol Lab, Bethesda, MD USA
[3] 15104 Forum Ave, Pflugerville, TX 78660 USA
关键词
Fertility preservation; Turner syndrome; Cryopreservation; Ethics; Innovative therapies;
D O I
10.1016/j.jpag.2023.08.005
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
Now that ovarian tissue cryopreservation (OTC) has become standard of care for patients receiving gonadotoxic therapies, discussion has turned toward offering OTC to pediatric patients with Turner syndrome outside of research. Although patients with Turner syndrome have unmet fertility needs and the authors support effort s f or fertility preservation in these individuals, safety and efficacy data about OTC in this population are limited. Building on longstanding debates around offering experimental therapies as research or outside of research (as "innovative therapy"), we considered the suitability of offering OTC for patients with Turner syndrome as innovative therapy. On the basis of pathophysiology and preliminary research data, we argue that there is significant uncertainty about whether the risk benefit profile of OTC for patients with Turner syndrome is favorable. This reduces the weight of arguments in favor of offering it as innovative therapy. Furthermore, as Turner syndrome is rare, widespread availability of OTC could make it difficult to develop generalizable knowledge. The benefits of innovative therapy for acquiring experience from use in humans and avoiding research-related procedures are of limited importance too, as OTC is already an established procedure, and current studies involve limited procedures that restrict access. OTC should therefore only be offered to patients with Turner syndrome in research settings until additional data suggest that the risk benefit profile is likely favorable.
引用
收藏
页码:566 / 568
页数:3
相关论文
共 7 条
[1]   Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine [J].
Earl, Jake .
AMERICAN JOURNAL OF BIOETHICS, 2019, 19 (06) :7-18
[2]  
Fleischer K, 2022, HUM REPROD, V37, pI420
[3]   Time to consider ovarian tissue cryopreservation for girls with Turner's syndrome: an opinion paper [J].
Jeve, Yadava Bapurao ;
Gelbaya, Tarek ;
Fatum, Muhammad .
HUMAN REPRODUCTION OPEN, 2019, 2019 (03)
[4]  
Mascoe C, 2023, J Pediatr Adolesc Gynecol, V36
[5]   Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion [J].
Penzias, Alan ;
Bendikson, Kristin ;
Falcone, Tommaso ;
Gitlin, Susan ;
Gracia, Clarisa ;
Hansen, Karl ;
Hill, Micah ;
Hurd, William ;
Jindal, Sangita ;
Kalra, Suleena ;
Mersereau, Jennifer ;
Odem, Randall ;
Racowsky, Catherine ;
Rebar, Robert ;
Reindollar, Richard ;
Rosen, Mitchell ;
Sandlow, Jay ;
Schlegel, Peter ;
Steiner, Anne ;
Tanrikut, Cigdem ;
Stovall, Dale .
FERTILITY AND STERILITY, 2019, 112 (06) :1022-1033
[6]   To Freeze or Not to Freeze? An Update on Fertility Preservation In Females with Turner Syndrome [J].
Schleedoorn, M. J. ;
van Alfen-van der Velden ;
Braat, D. D. M. ;
Peek, R. ;
Fleischer, K. .
PEDIATRIC ENDOCRINOLOGY REVIEWS PER, 2019, 16 (03) :369-382
[7]   Innovative treatment as a precursor to clinical research [J].
Wendler, David ;
Anjum, Seher ;
Williamson, Peter .
JOURNAL OF CLINICAL INVESTIGATION, 2021, 131 (15)