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JOURNAL ONKOLOGIE – STUDIE

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 Chair
University Hospital, Geneva

Kontakt

Studienlocations
(2 von 2)

Studien-Informationen

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

Ein-/Ausschlusskriterien

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

Studien-Rationale

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

Geprüfte Regime

  • ovarian tissue biopsy:
    ovarian tissue biopsy during general anesthesia

Quelle: ClinicalTrials.gov


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