AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age3-14
SponsorErasme University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
275 Participants
are divided into 3 treatment groupsGroup A: High risk1 intervention
Group B: Moderate/low risk1 intervention
Group C: No risk1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year oldSecondary outcomes
1
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
Time frame
screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old2
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
Time frame
screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year oldSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasme University Hospital
Lead sponsor
Queen Fabiola Children's University Hospital
Collaborator
Source ClinicalTrials.gov