Development of Ovarian Tissue Autograft to Restore Ovarian Function: Protocol for a French Multicenter Cohort Study.
cohort study
cryopreservation
fertility preservation
live birth rate
ovarian tissue
pregnancy rate
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
30 09 2019
30 09 2019
Historique:
received:
28
11
2018
accepted:
21
07
2019
revised:
24
06
2019
entrez:
2
10
2019
pubmed:
2
10
2019
medline:
2
10
2019
Statut:
epublish
Résumé
Sterility is a major late effect of radiotherapy and chemotherapy treatments. Iatrogenic sterility is often permanent and greatly impacts long-term quality of life. Ovarian tissue cryopreservation (OTC) performed before gonadotoxic treatments with subsequent autograft is a method of fertility preservation available for girls and women. Its application in prepubertal girls is of particular value as it is the only possible approach in this patient group. In addition, it does not require a delay in cancer therapy and no ovarian stimulation is needed. The primary aim of this protocol is to help increase the implementation of ovarian tissue autografting in France. Knowledge is still lacking regarding the efficacy of ovarian transplantation in restoring ovarian function and regarding the safety of this procedure, especially the risk of cancer cell reseeding in certain types of cancer. A secondary aim of this study is to generate data to improve our understanding of these two essential aspects. The DATOR (Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function) study is ongoing in 17 university hospitals. The DATOR protocol includes the autograft of ovarian cortex fragments. Candidates are identified from an observational prospective cohort (called the Prospective Cohort of Patients Candidates for Ovarian Tissue Autograft [PERIDATOR]) of patients who have undergone OTC. Enrollment in the study is initiated at the patient's request and must be validated by the center's multidisciplinary team and by the study steering committee. The DATOR study begins with a total medical checkup. Ovarian tissue qualification and residual disease detection, if required, are performed. The study is ongoing. Currently, 38 patients have provided informed consent and have been entered into the DATOR study. Graft has been performed for 34 of these patients. An interim analysis was conducted on the first 25 patients for whom the period of at least 1 year posttransplantation was achieved. Out of these 25 patients, 11 women succeeded in becoming pregnant (pregnancy rate=44% [11/25]; delivery rate=40% [10/25]). Among these, 6 women conceived twice, and 1 pregnancy led to a miscarriage. Our preliminary analysis appears to be coherent with the accumulating body of evidence indicating the potential utility of ovarian tissue autograft for patients with premature ovarian failure. All these elements justify the pursuit of our study. ClinicalTrials.gov NCT02846064; https://clinicaltrials.gov/ct2/show/NCT02846064. DERR1-10.2196/12944.
Sections du résumé
BACKGROUND
Sterility is a major late effect of radiotherapy and chemotherapy treatments. Iatrogenic sterility is often permanent and greatly impacts long-term quality of life. Ovarian tissue cryopreservation (OTC) performed before gonadotoxic treatments with subsequent autograft is a method of fertility preservation available for girls and women. Its application in prepubertal girls is of particular value as it is the only possible approach in this patient group. In addition, it does not require a delay in cancer therapy and no ovarian stimulation is needed.
OBJECTIVE
The primary aim of this protocol is to help increase the implementation of ovarian tissue autografting in France. Knowledge is still lacking regarding the efficacy of ovarian transplantation in restoring ovarian function and regarding the safety of this procedure, especially the risk of cancer cell reseeding in certain types of cancer. A secondary aim of this study is to generate data to improve our understanding of these two essential aspects.
METHODS
The DATOR (Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function) study is ongoing in 17 university hospitals. The DATOR protocol includes the autograft of ovarian cortex fragments. Candidates are identified from an observational prospective cohort (called the Prospective Cohort of Patients Candidates for Ovarian Tissue Autograft [PERIDATOR]) of patients who have undergone OTC. Enrollment in the study is initiated at the patient's request and must be validated by the center's multidisciplinary team and by the study steering committee. The DATOR study begins with a total medical checkup. Ovarian tissue qualification and residual disease detection, if required, are performed.
RESULTS
The study is ongoing. Currently, 38 patients have provided informed consent and have been entered into the DATOR study. Graft has been performed for 34 of these patients. An interim analysis was conducted on the first 25 patients for whom the period of at least 1 year posttransplantation was achieved. Out of these 25 patients, 11 women succeeded in becoming pregnant (pregnancy rate=44% [11/25]; delivery rate=40% [10/25]). Among these, 6 women conceived twice, and 1 pregnancy led to a miscarriage.
CONCLUSIONS
Our preliminary analysis appears to be coherent with the accumulating body of evidence indicating the potential utility of ovarian tissue autograft for patients with premature ovarian failure. All these elements justify the pursuit of our study.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02846064; https://clinicaltrials.gov/ct2/show/NCT02846064.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/12944.
Identifiants
pubmed: 31573931
pii: v8i9e12944
doi: 10.2196/12944
pmc: PMC6802486
doi:
Banques de données
ClinicalTrials.gov
['NCT02846064']
Types de publication
Journal Article
Langues
eng
Pagination
e12944Investigateurs
Frédérique Dijoud
(F)
Germain Agnani
(G)
Pierre-Simon Rorhlich
(PS)
Christophe Piguet
(C)
Brigitte Mignot
(B)
Eric Deconink
(E)
Christophe Borg
(C)
Francine Arbez Gindre
(F)
Paul Barrière
(P)
Frédérique Carre Pigeon
(F)
Blandine Courbière
(B)
Christine Decanter
(C)
Marie-Catherine Diligent
(MC)
Olivier Graesslin
(O)
Aurore Guennifey
(A)
Sylviane Hennebicq
(S)
Claude Hocke
(C)
Pascale Hoffmann
(P)
Isabelle Koscinski
(I)
Florence Leperlier
(F)
Brigitte Leroy
(B)
Loïc Marpeau
(L)
Catherine Metzler Guillemain
(C)
Aline Papaxanthos
(A)
Jean Parinaud
(J)
Jean-Christophe Pech
(JC)
Anne Perdrix
(A)
Olivier Pirrello
(O)
Marius Teletin
(M)
Pascal Piver
(P)
Benoît Resch
(B)
Nathalie Rives
(N)
Jacques Villière
(J)
Denis Vinatier
(D)
Annie Zaccabri
(A)
Roger Leandri
(R)
Carole Fajau Prevot
(C)
Florence Eustache
(F)
Michael Grynberg
(M)
Rajeev Ramanah
(R)
Florence Brugnon
(F)
Anne-Sophie Gremeau
(AS)
Elodie Adda Herzog
(E)
Valérie Scarabin Carre
(V)
Nelly Achour Frydman
(N)
Pascale Lagre
(P)
Beatrice Delepine
(B)
Ghassan Harika
(G)
Rachel Levy
(R)
Nathalie Chabbert Buffet
(N)
Marcos Ballester
(M)
Cécile Mezan de Malartic
(C)
Bénédicte Paillusson
(B)
Florence Boitrelle
(F)
Informations de copyright
©Jean-Baptiste Pretalli, Sophie Frontczak Franck, Lionel Pazart, Christophe Roux, Clotilde Amiot, DATOR Group. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.09.2019.
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