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

Not Applicable

Recruiting

• Conditions: Childhood Cancer; Fertility Disorders
• Interventions: Procedure: ovarian tissue biopsy

• Registration Number: NCT03180827
• Lead Sponsor: Gumy-Pause Fabienne

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02
• Primary Completion: 2100-01
• Study Completion: 2100-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ovarian tissue cryopreservation	ovarian tissue biopsy	-

Primary Outcome Measures

Name	Time	Method
Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation	0-20 years

Secondary Outcome Measures

Name	Time	Method
Incidence of complications related to the ovarian biopsy (safety)	0-20 years	The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection)
Comparison of biochemical markers	0-20 years	Comparison of biochemical markers (e.g., FSH; LH, AMH, progesterone, oestradiol) between patients who undergo ovarian biopsy and controls

Trial Locations

Locations (2)

CHUV; 🇨🇭 Lausanne, Switzerland

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland