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

NCT ID: NCT03180827

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2100-01-31

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

Detailed Description

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Conditions

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Childhood Cancer Fertility Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ovarian tissue cryopreservation

Group Type EXPERIMENTAL

ovarian tissue biopsy

Intervention Type PROCEDURE

ovarian tissue biopsy during general anesthesia

Interventions

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ovarian tissue biopsy

ovarian tissue biopsy during general anesthesia

Intervention Type PROCEDURE

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
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gumy-Pause Fabienne

OTHER

Sponsor Role lead

Responsible Party

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Gumy-Pause Fabienne

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fabienne Gumy-Pause, Dr

Role: STUDY_CHAIR

University Hospital, Geneva

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status RECRUITING

CHUV

Lausanne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Fabienne Gumy-Pause, Dr

Role: CONTACT

Facility Contacts

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Fabienne Gumy-Pause, Dr

Role: primary

Maja Beck Popovic, Prof

Role: primary

Other Identifiers

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PB_2017-00536 (15-073)

Identifier Type: -

Identifier Source: org_study_id

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