Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 28, 2018
Open Peer Review Period: Dec 4, 2018 - Jan 29, 2019
Date Accepted: Jul 21, 2019
(closed for review but you can still tweet)
Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function (DATOR): a French multicenter cohort study.
ABSTRACT
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 our 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 also regarding the safety of this procedure, especially the risk of cancer cell reseeding in certain types of cancer. A secondary aim of our study is to generate data to improve our understanding of these two essential aspects.
Methods:
The PERIDATOR-DATOR program is ongoing in 17 university hospitals and comprises 2 studies. The first, named PERIDATOR, consists in the constitution of an observational prospective cohort of patients who have undergone OTC. Follow-up comprises annual clinical, hormonal and ultrasound assessments by a biologist and a gynecologist. The second study, DATOR, consists in the autograft of ovarian fragments. This 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 check-up. Ovarian tissue qualification, and residual disease detection if required, are performed.
Results:
The program is ongoing. Currently, 106 patients have provided informed consent and have been entered into the PERIDATOR cohort. Among these, 38 were enrolled in the DATOR study. An interim analysis was conducted on the first 15 patients for whom the period of one year post-transplantation was achieved. Eight women out of these 15 succeeded in becoming pregnant (pregnancy rate=53.3%). Among these, 2 conceived twice and 1 pregnancy led to a miscarriage (delivery rate=46.7%).
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. Clinical Trial: Clinicaltrials.gov NCT02846064 https://clinicaltrials.gov/ct2/show/NCT02846064
Citation
Per the author's request the PDF is not available.
Copyright
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