Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment

Gumy-Pause Fabienne

Status: Enrolling

Conditions: Fertility Disorders; Childhood Cancer

Treatments: Procedure: ovarian tissue biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03180827

PB_2017-00536 (15-073)

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 2 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ovarian tissue cryopreservation

Experimental group

Treatment:

Procedure: ovarian tissue biopsy