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

Study Overview
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Brief Summary
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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

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

Conditions
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Childhood Cancer, Fertility Disorders

Intervention / Treatment
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* Procedure: ovarian tissue biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ovarian tissue cryopreservation<br> | Procedure: ovarian tissue biopsy<br>* ovarian tissue biopsy during general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation |  | 0-20 years | 

Secondary Outcome Measures

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