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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180827
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gumy-Pause Fabienne, University Hospital, Geneva

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 prepubertal and pubertal 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

Monocentric study: HUG


Condition or disease Intervention/treatment Phase
Childhood Cancer Fertility Disorders Procedure: ovarian tissue biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
Actual Study Start Date : June 2015
Estimated Primary Completion Date : January 2100
Estimated Study Completion Date : January 2100

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: ovarian tissue cryopreservation Procedure: ovarian tissue biopsy
ovarian tissue biopsy during general anesthesia




Primary Outcome Measures :
  1. Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation [ Time Frame: 0-20 years ]

Secondary Outcome Measures :
  1. 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)

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric pubertal and prepubertal 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180827


Contacts
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Contact: Fabienne Gumy-Pause, Dr fabienne.gumypause@hcuge.ch

Locations
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Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1211
Contact: Fabienne Gumy-Pause, Dr       fabienne.gumypause@hcuge.ch   
Sponsors and Collaborators
Gumy-Pause Fabienne

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Responsible Party: Gumy-Pause Fabienne, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03180827    
Other Study ID Numbers: 15-073
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No