Fertility and Ovarian Reserve in Female Childhood Cancer Survivors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorCentre Hospitalier Universitaire de Liege

About this trial

Ovarian function impairment affects the quality of life of the survivors of paediatric cancer by impacting fertility, bone quality and mental and cognitive health. The objective of this project is to evaluate the impact of low-intermediate dose alkylating agents associated or not with ovarian cryopreservation technique on ovarian function in female survivors of paediatric cancer. We propose to identify new epigenetic markers in order to predict the risk of premature ovarian insufficiency. The project will be led by a national multi-disciplinary team (paediatric oncologists, gynaecologists, endocrinologists). Paediatric cancer clinical data (therapy, fertility preservation, ...) will be extracted from the Paediatrics Late Effects database and additional data will be collected during PRINCESS fertility evaluation. Through translational and multi-disciplinary approaches, results should improve quality of life and fertility preservation in female survivors of paediatric cancer by developing new personalised screening tools for premature ovarian insufficiency.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

diagnosed with cancer1 between 01/01/2004 and 31/12/2018

<17 years old at diagnosis

treated at CHU Liège site Citadelle or CHC, Cliniques Universitaires Saint-Luc and HUDERF

alive

Disqualifiers

Cancer diagnosis for controls

Trial population

Child and adolescent female patients included in the Paediatrics Late Effects Project. Controls will be age-, sex- and socio-economic-matched individuals starting with the siblings of the survivors. Belgian (http://statbel.fgov.be/en) public demographic, socioeconomic and birth registries will be used to exclude any bias in controls recruitment.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

The index of fertility

having children among survivors in compared with controls

Time frame
2027
2

The rate of menopause and POI

Number of participants in POI

Time frame
2027
3

The rate of premature or delayed puberty

Number of participants with premature/delayed puberty

Time frame
2027
4

The rate of negative pregnancy outcome (miscarriage, medical abortion, stillbirth or birth

Number of participants with pregnancy problems

Time frame
2028

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Liege

Lead sponsor

La Fondation contre le cancer, Belgique

Collaborator