- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03180918
Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment
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, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed.
Primary aims
- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment.
Secondary aims
- To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility
- To create a database in order to record clinical and biological follow-up data
- To create a research biobank for future research projects
Multicentric study: HUG, CHUV, UKBB
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fabienne Gumy-Pause, Dr
- Email: fabienne.gumypause@hcuge.ch
Study Locations
-
-
-
Basel, Switzerland
- Recruiting
- UKBB
-
Contact:
- Tamara Diesch-Furlanetto, Dr
-
Geneva, Switzerland, 1211
- Recruiting
- Geneva University Hospitals
-
Contact:
- Fabienne Gumy-Pause, Dr
- Email: fabienne.gumypause@hcuge.ch
-
Lausanne, Switzerland
- Recruiting
- CHUV
-
Contact:
- Maja Beck Popovic, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Prepubertal patients aged 3 months and older
- Peri and pubertal patients after failure of sperm cryopreservation
- Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
- Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue
Exclusion Criteria:
- Patients under the age of 3 months
- Refusal of the patient and/or his parents
- Treatments that are not highly gonadotoxic
Study Plan
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: testicular tissue cryopreservation
|
testicular 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 testicular 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 testicular 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, testicular atrophy)
|
0-20 years
|
Comparison of biochemical markers
Time Frame: 0-20 years
|
Comparison of biochemical markers (e.g., FSH; LH, AMH; Inhibin B, SHBG and testosterone) between patients who undergo testicular biopsy and controls
|
0-20 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Fabienne Gumy-Pause, University Hospital, Geneva
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PB_2016-01378
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Childhood Cancer
-
Australian & New Zealand Children's Haematology...Medical Research Future Fund; Minderoo Foundation; Children's Cancer Institute...RecruitingChildhood Cancer | Relapsed Cancer | Refractory Cancer | Childhood Leukemia | Childhood Solid Tumor | Childhood Brain TumorAustralia
-
Sydney Children's Hospitals NetworkGerman Cancer Research Center; Australian & New Zealand Children's Haematology... and other collaboratorsRecruitingChildhood Cancer | Relapsed Cancer | Refractory Cancer | Childhood Leukemia | Childhood Solid Tumor | Childhood Brain TumorAustralia
-
University of Colorado, DenverRecruitingCancer | Childhood CancerUnited States
-
Children's Hospital of PhiladelphiaCompletedCancer | Childhood CancerUnited States
-
Wake Forest University Health SciencesTerminated
-
Gustave Roussy, Cancer Campus, Grand ParisActive, not recruiting
-
Pernille BidstrupOdense University Hospital; Aarhus University Hospital; Aarhus University Hospital... and other collaboratorsCompleted
-
Emory UniversityNational Cancer Institute (NCI)Recruiting
-
Children's Cancer Group, ChinaShanghai Children's Medical Center; Shanghai Municipal Center for Disease Prevention...Recruiting
-
St. Jude Children's Research HospitalRecruiting
Clinical Trials on testicular tissue biopsy
-
Universitair Ziekenhuis BrusselRecruitingHematologic Diseases | Cancer | Sickle Cell ThalassemiaBelgium
-
University of EdinburghUniversity of OxfordRecruitingChildhood Cancer | Fertility DisordersUnited Kingdom
-
Fundación IVIRecruitingDNA Damage | IVF | Oligospermia | ICSI | EmbryoSpain
-
University of PittsburghWashington University School of Medicine; University of Miami; University of... and other collaboratorsRecruitingCancer | Autoimmune DisordersUnited States
-
Odense University HospitalCompleted
-
Cliniques universitaires Saint-Luc- Université...RecruitingInfertility, Male | Klinefelter SyndromeBelgium
-
University of Colorado, DenverWithdrawn
-
Boston Children's HospitalCompleted
-
Centre Hospitalier Universitaire de NiceTerminatedTesticular CancerFrance