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Clinical Trials/NCT03180827
NCT03180827
Recruiting
Not Applicable

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

Gumy-Pause Fabienne2 sites in 1 country100 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Cancer
Sponsor
Gumy-Pause Fabienne
Enrollment
100
Locations
2
Primary Endpoint
Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation
Status
Recruiting
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
January 2100
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Gumy-Pause Fabienne
Responsible Party
Sponsor Investigator
Principal Investigator

Gumy-Pause Fabienne

Principal Investigator

University Hospital, Geneva

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation

Time Frame: 0-20 years

Secondary Outcomes

  • Incidence of complications related to the ovarian biopsy (safety)(0-20 years)
  • Comparison of biochemical markers(0-20 years)

Study Sites (2)

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