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

Sponsor

Gumy-Pause Fabienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT03180827

Collaborator

(none)

100

Enrollment

Locations

Arm

1015

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer Fertility Disorders	Procedure: ovarian tissue biopsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

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 :

Jun 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2100

Anticipated Study Completion Date :

Jan 1, 2100

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ovarian tissue cryopreservation

Procedure: ovarian tissue biopsy

ovarian tissue biopsy during general anesthesia

Outcome Measures

Primary Outcome Measures

Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation [0-20 years]

Secondary Outcome Measures

Incidence of complications related to the ovarian biopsy (safety) [0-20 years]
The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection)
Comparison of biochemical markers [0-20 years]
Comparison of biochemical markers (e.g., FSH; LH, AMH, progesterone, oestradiol) between patients who undergo ovarian biopsy and controls

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva University Hospitals	Geneva		Switzerland	1211
2	CHUV	Lausanne		Switzerland

Sponsors and Collaborators

Gumy-Pause Fabienne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gumy-Pause Fabienne, Principal Investigator, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT03180827

Other Study ID Numbers:

PB_2017-00536 (15-073)

First Posted:

Jun 8, 2017

Last Update Posted:

Aug 13, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 13, 2021