Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
1 other identifier
interventional
100
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 31, 2017
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2100
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2100
November 2, 2022
November 1, 2022
84.6 years
May 31, 2017
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation
0-20 years
Secondary Outcomes (2)
Incidence of complications related to the ovarian biopsy (safety)
0-20 years
Comparison of biochemical markers
0-20 years
Study Arms (1)
ovarian tissue cryopreservation
EXPERIMENTALInterventions
ovarian tissue biopsy during general anesthesia
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient under the age of 2 months
- Refusal of the patient and/or her parents
- Treatments that are not highly gonadotoxic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Geneva University Hospitals
Geneva, 1211, Switzerland
CHUV
Lausanne, Switzerland
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Fabienne Gumy-Pause, Dr
University Hospital, Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 31, 2017
First Posted
June 8, 2017
Study Start
June 1, 2015
Primary Completion (Estimated)
January 1, 2100
Study Completion (Estimated)
January 1, 2100
Last Updated
November 2, 2022
Record last verified: 2022-11