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

November 1, 2022 updated by: Gumy-Pause Fabienne

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
      • Lausanne, Switzerland
        • Recruiting
        • CHUV
        • Contact:
          • Maja Beck Popovic, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ovarian tissue cryopreservation
Procedure: ovarian tissue biopsy
ovarian tissue biopsy during general anesthesia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications related to the ovarian biopsy (safety)
Time Frame: 0-20 years
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
Time Frame: 0-20 years
Comparison of biochemical markers (e.g., FSH; LH, AMH, progesterone, oestradiol) between patients who undergo ovarian biopsy and controls
0-20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gumy-Pause Fabienne

Investigators

  • Study Chair: Fabienne Gumy-Pause, Dr, University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Anticipated)

January 1, 2100

Study Completion (Anticipated)

January 1, 2100

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PB_2017-00536 (15-073)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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