Childhood CancerNCT03180827
Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
A study testing ovarian tissue biopsy in people with Childhood Cancer and Fertility Disorders, run by Gumy-Pause Fabienne at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 18 years, women only
- Conditions the study is for
- Childhood Cancer, Fertility Disorders
- What is being tested?
- ovarian tissue biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jun 2015to Jan 2100
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patient under the age of 2 months
- Refusal of the patient and/or her parents
- Treatments that are not highly gonadotoxic
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read more
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
- Conditions
- Childhood Cancer, Fertility Disorders
- Being tested
- ovarian tissue biopsy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian tissue biopsyProcedure or surgery
ovarian tissue biopsy during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| ovarian tissue cryopreservation | Experimental | Not described Receives: Procedure: ovarian tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation
Measured: 0-20 years
Secondary outcomes (2)
Incidence of complications related to the ovarian biopsy (safety)
The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection)
Measured: 0-20 years
Comparison of biochemical markers
Comparison of biochemical markers (e.g., FSH; LH, AMH, progesterone, oestradiol) between patients who undergo ovarian biopsy and controls
Measured: 0-20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study startJun 2015
- Primary completionJan 2100 (estimated)
- Study completionJan 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gumy-Pause Fabienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gumy-Pause Fabienne, University Hospital, Geneva
- Investigators
- Fabienne Gumy-Pause, Dr, Study chair, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180827
- Sponsor's protocol ID
- PB_2017-00536 (15-073)
- Status last verified
- May 2026
- First submitted
- 31 May 2017
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
- ClinicalTrials.gov ID
- NCT03180827
- Acronym / sponsor ID
- PB_2017-00536 (15-073)
- Conditions
- Childhood Cancer, Fertility Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gumy-Pause FabienneUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2100 (estimated)
- Study completion
- Jan 2100 (estimated)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ovarian tissue cryopreservation | Experimental | Procedure: ovarian tissue biopsy |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient under the age of 2 months
- Refusal of the patient and/or her parents
- Treatments that are not highly gonadotoxic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ovarian tissue biopsyovarian tissue biopsy during general anesthesia | Procedure or surgery | ovarian tissue cryopreservation |
Primary outcome
Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation
Time frame: 0-20 years
2 secondary outcomes
Incidence of complications related to the ovarian biopsy (safety)
Time frame: 0-20 years
Comparison of biochemical markers
Time frame: 0-20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne Gumy-Pause, Dr study chair
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ovarian tissue biopsy in people with Childhood Cancer and Fertility Disorders, run by Gumy-Pause Fabienne at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation (time frame: 0-20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.