Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
Rekrutierend
NCT-Nummer:
NCT03180827
Studienbeginn:
Juni 2015
Letztes Update:
02.11.2022
Wirkstoff:
-
Geschlecht:
Frauen
Altersgruppe:
Kinder (0-17)
Phase:
-
Sponsor:
Gumy-Pause Fabienne
Collaborator:
-
Studienleiter
Fabienne Gumy-Pause, Dr Study ChairUniversity Hospital, Geneva
Kontakt
Fabienne Gumy-Pause, Dr Kontakt: E-Mail: fabienne.gumypause@hcuge.ch» Kontaktdaten anzeigen
Brief Summary: Background: Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, only the experimental option of ovarian tissue cryopreservation can be proposed to prepubertal girls with a high risk of infertility. For pubertal patient, cryopreservation of mature oocytes after ovarian stimulation can be offered if oncological treatment debut can be delayed. As it is often not possible, ovarian tissue cryopreservation can also be offered. Primary aims - To cryopreserve ovarian tissue of pre or peripubertal patient who will be receiving highly gonadotoxic oncological treatment. Secondary aims - To create a database in order to record clinical and biological follow-up data - To pool resources with Fertisave Registry - To create a research biobank for future research projects Multicentric study: HUG, CHUV
Inclusion Criteria: - Pediatric pre ou peripubertal patient aged 2 months and older - Patient presenting high risk of infertility because of gonadotoxic treatments (i.e. high dose of alkylating agents, ovarian irradiation, total body irradiation) - Multidisciplinary team consensus in favour to proposition to cryopreserve ovarian tissue.Exclusion Criteria: - Patient under the age of 2 months - Refusal of the patient and/or her parents - Treatments that are not highly gonadotoxic
Primary outcome: 1. Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation (Time Frame - 0-20 years)Secondary outcome: 1. Incidence of complications related to the ovarian biopsy (safety) (Time Frame - 0-20 years):The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection) 2. Comparison of biochemical markers (Time Frame - 0-20 years):Comparison of biochemical markers (e.g., FSH; LH, AMH, progesterone, oestradiol) between patients who undergo ovarian biopsy and controls
ovarian tissue biopsy:ovarian tissue biopsy during general anesthesia
Quelle: ClinicalTrials.gov
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