Fertility PreservationCHANCENCT02595255
AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)
An observational study of Fertility Preservation and Lymphoma, run by Erasme University Hospital at 8 sites in 2 countries.
Trial summary
While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Read more about this study
- Who is it for?
- Ages 3 to 14 years, women only
- Conditions the study is for
- Fertility Preservation, Lymphoma, Pediatrics Cancer
- How many people
- 275 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2014to 31 Dec 2041
- Phase
- Observational
- 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 3 to 14 years
- Women only
- No healthy volunteers
- Child
Study population: The population for this trial is patients between 3 and 14 year old newly diagnosed with cancer or benign diseases treated by chemotherapy and/or pelvic irradiation with high or moderate risk of inducing premature ovarian insufficiency. The "no risk" group includes patients with chronic benign diseases (as pneumology or gastroenterology diseases, congenital hypothyroidism, growth hormone deficiency or RCIU…) or malignancies who will not receive any chemotherapy or other gonadotoxic treatment.
Who may be able to join
- Patients from 3 to 14 year old included - Belong to one of these 3 groups (modified from Wallace et al, 2005):
- High risk : Conditioning therapy for bone marrow transplantation or pelvic irradiation
- Moderate/Low risk : Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML, osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL, Wilms tumour, retinoblastoma.
- No risk (control group) : patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment.
Who cannot join
- CNS (central nervous system) irradiation, cerebral tumour
- Current or previous ovarian disease/surgery
- Familial history of premature ovarian failure (no iatrogenic or surgical origins)
- Previous known severe chronic disease potentially affecting normal growth or puberty (diseases inducing malnutrition, anorexia, genetic/congenital disorders as Turner, Kallman, BPES(Blepharophimosis, ptosis, and epicanthus inversus syndrome) syndromes, uncontrolled severe diabetes, Cushing Syndrome, auto-immune diseases, cystic fibrosis, severe renal dysfunction)
- Genetic/congenital disorders inducing mental retardation
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Belgium6 sites, 6 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
Caroline De Schepper, +32 3 821 58 39, caroline.deschepper@uza.be
Joris Verlooy
- Recruiting
Hôpital Universitaire Reine Fabiola (HUDERF)
Brussels, 1020
Merry Vanpuyvelde, +32 2 477 38 85, merry.vanpuyvelde@huderf.be
Bernard Wenderickx, +32 2 477 36 54, bernard.wenderickx@huderf.be
- Recruiting
Universitair Ziekenhuis Brussels
Brussels, 1090
Wiert Robberechts, +32 2 801 28 14, Wiert.Robberechts@uzbrussel.be
Jutte Van der Werff
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
Anouk Peeters, +32 16 34 52 99, anouk.1.peeters@uzleuven.be
Anne Uyttebroeck
- Recruiting
Centre Hospitalier Régional (CHR)-Citadelle
Liège, 4000
Catherine Sondag, +32 4 321 89 77, Catherine.Sondag@chrcitadelle.be
Caroline Piette
- Recruiting
Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance
Montegnée, Liège, 4420
Audrey Courtois, +32 4 355 42 21, audrey.courtois@chc.be
Nadine Francotte
France2 sites, 2 recruiting
- Recruiting
Centre Oscar Lambret
Lille, 59000
Sandy Vandermeersch, +33 3 20 29 58 26, s-vandermeersch@o-lambret.fr
Hélène Sudour-Bonnange
- Recruiting
CHRU Lille-Hôpital Jeanne de Flandre
Lille, 59037
Angéline Morel, +33 3 20 44 60 58 ext. 31422, angeline.morel@chru-lille.fr
Benedicte Bruno
About this study
Official title: Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal/Pubertal Cancer Patients
While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Fertility preservation is currently proposed for selected prepubertal patients with a high risk of premature ovarian failure after treatment (mostly conditioning regimen for bone marrow transplantation). For patients with low or moderate risks, counselling is very difficult and no fertility preservation procedure is usually proposed for these patients as no marker of the ovarian reserve has been validated in this young population to assess the individual risk.
The primary objective of the study is to prevent long-term treatment-related infertility by detecting the young patients who normally progressed to menarche but have a reduced ovarian reserve. These patients may benefit from particular follow-up and fertility preservation procedure.
Read the detailed description
In this clinical trial, we will prospectively evaluate the AMH (Antimüllerian Hormone) level before and after treatment (up to 18 years old) in a large cohort of pre- and post-pubertal children treated for cancer. The children enrolled are young patients between 3 and 14 year old who are newly diagnosed with cancer or benign diseases treated by chemotherapy and/or pelvic irradiation. They belong to one of these 3 groups (modified from Wallace et al, 2005):
- High risk
- Moderate/Low risk
- No risk (control group)
Primary endpoint:
Evaluate AMH as a potential biomarker of ovarian reserve in prepubertal/pubertal girl treated by chemotherapy (classified according to the AAD(Alkylating Agent Dose) score)
Secondary endpoints:
- Evaluate the association between the post-treatment ovarian reserve and the AMH pretreatment values in patients considered as moderate or low risk.
- Identify new patients group who may benefit from fertility preservation
- Compare the gonadotoxicity of chemotherapy regimen according to the pubertal status.
- Study the relation between the AMH levels and the pubertal age, menstruation cycle regularity, hormonal levels (FSH (follicle stimulating hormone), œstradiol, and testosterone) and bone age.
Different parameters will be assessed at inclusion, end of the treatment and during the follow-up (every year during the first 3 years and then every 2 years until the end of the study) Oncological outcome The patients will be followed up for progression and survival as per standard local practice.
Ovarian reserve and function:
Ovarian reserve will be evaluated based on hormonal dosages at different times of the study: FSH, AMH, estradiol, testosterone and LH (luteinizing hormone). Menstrual function will be evaluated by collecting information of the pubertal status (spontaneous or induced puberty) and menstrual cycle characteristics
Puberty evaluation:
All children will have an evaluation of the TANNER pubertal stage at 9 years of age (or later if > 9 years old at the time of inclusion) and once a year until the end of puberty (when patients reach Tanner stage 5). An X-ray of the left hand and wrist will be carried out for bone age evaluation at 9-11 and 13 years old.
- Conditions
- Fertility Preservation, Lymphoma, Pediatrics Cancer, Gonadotropin-releasing Hormone Agonist
- Being tested
- No intervention
- Keywords
- chemotherapy, lymphoma, children, fertility, GnRH (gonadotropin-releasing hormone) analogues
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| High risk | Conditioning therapy for bone marrow transplantation or pelvic irradiation. Fertility preservation is usually already proposed in this group of patients. No intervention. Receives: Other: No intervention | |
| Moderate/low risk | Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML (Acute myeloid leukemia), osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL (acute lymphoblastic hormone), Wilms tumour, retinoblastoma.
This is the study group we will compare with high risk and no risk patients. No intervention Receives: Other: No intervention | |
| No risk | Patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment.
No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH marker
Blood test collection for serum storage. AMH values will be compared in the different groups and correlated with the cumulative doses of alkylating agents
Measured: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Secondary outcomes (2)
Premature ovarian failure (POF)
Blood test collection for serum storage. FSH, E2 and AMH measurement and pubertal status. POF rate will be compared between groups
Measured: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Ovarian reserve
relation between the AMH levels, pubertal age, menstruation cycle regularity, hormonal levels (FSH, œstradiol, and testosterone at 16 year old) and bone age
Measured: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fertility PreservationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Fabiola Children's University Hospital
- Responsible party
- Sponsor
- Investigators
- Isabelle Demeestere, PhD, Study director, Erasme ULB- BelgiumAlina Ferster, Principal investigator, Queen Fabiola children's university hospital- BelgiumChristine Decanter, Principal investigator, CHRU Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595255
- Sponsor's protocol ID
- CHANCE (CHildren, Amh, caNCEr)
- Acronym
- CHANCE
- Status last verified
- Dec 2024
- First submitted
- 2 Nov 2015
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Brougham MF, Crofton PM, Johnson EJ, Evans N, Anderson RA, Wallace WH. Anti-Mullerian hormone is a marker of gonadotoxicity in pre- and postpubertal girls treated for cancer: a prospective study. J Clin Endocrinol Metab. 2012 Jun;97(6):2059-67. doi: 10.1210/jc.2011-3180. Epub 2012 Apr 3.
PubMed 22472563Wallace WH, Smith AG, Kelsey TW, Edgar AE, Anderson RA. Fertility preservation for girls and young women with cancer: population-based validation of criteria for ovarian tissue cryopreservation. Lancet Oncol. 2014 Sep;15(10):1129-36. doi: 10.1016/S1470-2045(14)70334-1. Epub 2014 Aug 14.
PubMed 25130994Demeestere I, Simon P, Dedeken L, Moffa F, Tsepelidis S, Brachet C, Delbaere A, Devreker F, Ferster A. Live birth after autograft of ovarian tissue cryopreserved during childhood. Hum Reprod. 2015 Sep;30(9):2107-9. doi: 10.1093/humrep/dev128. Epub 2015 Jun 9.
PubMed 26062556Imbert R, Moffa F, Tsepelidis S, Simon P, Delbaere A, Devreker F, Dechene J, Ferster A, Veys I, Fastrez M, Englert Y, Demeestere I. Safety and usefulness of cryopreservation of ovarian tissue to preserve fertility: a 12-year retrospective analysis. Hum Reprod. 2014 Sep;29(9):1931-40. doi: 10.1093/humrep/deu158. Epub 2014 Jun 22.
PubMed 24958067
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal/Pubertal Cancer Patients
- ClinicalTrials.gov ID
- NCT02595255
- Acronym / sponsor ID
- CHANCE / CHANCE (CHildren, Amh, caNCEr)
- Conditions
- Fertility Preservation, Lymphoma, Pediatrics Cancer, Gonadotropin-releasing Hormone Agonist
- Keywords
- chemotherapy, lymphoma, children, fertility, GnRH (gonadotropin-releasing hormone) analogues
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Queen Fabiola Children's University Hospital
- Study start
- Apr 2014 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- 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.
While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Fertility preservation is currently proposed for selected prepubertal patients with a high risk of premature ovarian failure after treatment (mostly conditioning regimen for bone marrow transplantation). For patients with low or moderate risks, counselling is very difficult and no fertility preservation procedure is usually proposed for these patients as no marker of the ovarian reserve has been validated in this young population to assess the individual risk.
The primary objective of the study is to prevent long-term treatment-related infertility by detecting the young patients who normally progressed to menarche but have a reduced ovarian reserve. These patients may benefit from particular follow-up and fertility preservation procedure.
Detailed description
In this clinical trial, we will prospectively evaluate the AMH (Antimüllerian Hormone) level before and after treatment (up to 18 years old) in a large cohort of pre- and post-pubertal children treated for cancer. The children enrolled are young patients between 3 and 14 year old who are newly diagnosed with cancer or benign diseases treated by chemotherapy and/or pelvic irradiation. They belong to one of these 3 groups (modified from Wallace et al, 2005):
- High risk
- Moderate/Low risk
- No risk (control group)
Primary endpoint:
Evaluate AMH as a potential biomarker of ovarian reserve in prepubertal/pubertal girl treated by chemotherapy (classified according to the AAD(Alkylating Agent Dose) score)
Secondary endpoints:
- Evaluate the association between the post-treatment ovarian reserve and the AMH pretreatment values in patients considered as moderate or low risk.
- Identify new patients group who may benefit from fertility preservation
- Compare the gonadotoxicity of chemotherapy regimen according to the pubertal status.
- Study the relation between the AMH levels and the pubertal age, menstruation cycle regularity, hormonal levels (FSH (follicle stimulating hormone), œstradiol, and testosterone) and bone age.
Different parameters will be assessed at inclusion, end of the treatment and during the follow-up (every year during the first 3 years and then every 2 years until the end of the study) Oncological outcome The patients will be followed up for progression and survival as per standard local practice.
Ovarian reserve and function:
Ovarian reserve will be evaluated based on hormonal dosages at different times of the study: FSH, AMH, estradiol, testosterone and LH (luteinizing hormone). Menstrual function will be evaluated by collecting information of the pubertal status (spontaneous or induced puberty) and menstrual cycle characteristics
Puberty evaluation:
All children will have an evaluation of the TANNER pubertal stage at 9 years of age (or later if > 9 years old at the time of inclusion) and once a year until the end of puberty (when patients reach Tanner stage 5). An X-ray of the left hand and wrist will be carried out for bone age evaluation at 9-11 and 13 years old.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High risk | – | Other: No interventionConditioning therapy for bone marrow transplantation or pelvic irradiation. Fertility preservation is usually already proposed in this group of patients. No intervention. |
| Moderate/low risk | – | Other: No interventionPathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML (Acute myeloid leukemia), osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL (acute lymphoblastic hormone), Wilms tumour, retinoblastoma. This is the study group we will compare with high risk and no risk patients. No intervention |
| No risk | – | Other: No interventionPatients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment. No intervention |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The population for this trial is patients between 3 and 14 year old newly diagnosed with cancer or benign diseases treated by chemotherapy and/or pelvic irradiation with high or moderate risk of inducing premature ovarian insufficiency. The "no risk" group includes patients with chronic benign diseases (as pneumology or gastroenterology diseases, congenital hypothyroidism, growth hormone deficiency or RCIU…) or malignancies who will not receive any chemotherapy or other gonadotoxic treatment.
Key inclusion criteria (4 listed)
- Patients from 3 to 14 year old included - Belong to one of these 3 groups (modified from Wallace et al, 2005):
Key exclusion criteria (5 listed)
- CNS (central nervous system) irradiation, cerebral tumour
- Current or previous ovarian disease/surgery
- Familial history of premature ovarian failure (no iatrogenic or surgical origins)
- Previous known severe chronic disease potentially affecting normal growth or puberty (diseases inducing malnutrition, anorexia, genetic/congenital disorders as Turner, Kallman, BPES(Blepharophimosis, ptosis, and epicanthus inversus syndrome) syndromes, uncontrolled severe diabetes, Cushing Syndrome, auto-immune diseases, cystic fibrosis, severe renal dysfunction)
- Genetic/congenital disorders inducing mental retardation
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 |
|---|---|---|
| No interventionNo intervention | Other | High risk, Moderate/low risk, No risk |
Primary outcome
AMH marker
Time frame: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Blood test collection for serum storage. AMH values will be compared in the different groups and correlated with the cumulative doses of alkylating agents
2 secondary outcomes
Premature ovarian failure (POF)
Time frame: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Ovarian reserve
Time frame: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
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 12 Aug 2026.
- Background: PubMed 22472563Brougham MF, Crofton PM, Johnson EJ, Evans N, Anderson RA, Wallace WH. Anti-Mullerian hormone is a marker of gonadotoxicity in pre- and postpubertal girls treated for cancer: a prospective study. J Clin Endocrinol Metab. 2012 Jun;97(6):2059-67. doi: 10.1210/jc.2011-3180. Epub 2012 Apr 3.
- Background: PubMed 25130994Wallace WH, Smith AG, Kelsey TW, Edgar AE, Anderson RA. Fertility preservation for girls and young women with cancer: population-based validation of criteria for ovarian tissue cryopreservation. Lancet Oncol. 2014 Sep;15(10):1129-36. doi: 10.1016/S1470-2045(14)70334-1. Epub 2014 Aug 14.
- Background: PubMed 26062556Demeestere I, Simon P, Dedeken L, Moffa F, Tsepelidis S, Brachet C, Delbaere A, Devreker F, Ferster A. Live birth after autograft of ovarian tissue cryopreserved during childhood. Hum Reprod. 2015 Sep;30(9):2107-9. doi: 10.1093/humrep/dev128. Epub 2015 Jun 9.
- Background: PubMed 24958067Imbert R, Moffa F, Tsepelidis S, Simon P, Delbaere A, Devreker F, Dechene J, Ferster A, Veys I, Fastrez M, Englert Y, Demeestere I. Safety and usefulness of cryopreservation of ovarian tissue to preserve fertility: a 12-year retrospective analysis. Hum Reprod. 2014 Sep;29(9):1931-40. doi: 10.1093/humrep/deu158. Epub 2014 Jun 22.
Related trials for Fertility Preservation
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
Not yet recruitingObservational study
Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue
Fertility, Testicular Tissue Cryopreserved
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingObservational study
Follicular Flushing Versus Direct Aspiration in Transabdominal Oocyte Retrieval
Fertility Preservation
Recruiting
Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors
Unmet Fertility Information Needs
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.
Isabelle Demeestere, PhD study director
Erasme ULB- Belgium
Alina Ferster principal investigator
Queen Fabiola children's university hospital- Belgium
Christine Decanter principal investigator
CHRU Lille, France
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Preservation and Lymphoma, run by Erasme University Hospital at 8 sites in 2 countries.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, France. 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?
Contact Isabelle Demeestere, PhD (+32 2 555 65 92, isabelle.demeestere@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH marker (time frame: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595255, which also lists 4 linked publications.
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 12 Aug 2026.