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

Qualifiers

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 design

Treatments tested in this trial

  • No intervention

Treatment groups

275 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Erasme University Hospital

Lead sponsor

Queen Fabiola Children's University Hospital

Collaborator