BridgeMD
ProFertil
EU CTIS ID: 2024-518977-32-00
What this study is testing
To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the Anti-Müllerian Hormone (AMH) at 12 months after end of gonadotoxic treatment (EOT) in women with breast cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent
- Age 14-42 years at cancer diagnosis
- Female subjects with breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for disease-specific chemotherapy
- Confirmed menarche
- ECOG performance status 0-1
- Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders
You likely can't join if
- Ongoing treatment with GnRHa at baseline
- Direct radiation of the gonads previous or planned (total body irradiation allowed)
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data
- Previous or planned bilateral oophorectomy
- Pregnancy or breastfeeding at time of start of chemotherapy
See the full eligibility criteria
- Signed informed consent
- Age 14-42 years at cancer diagnosis
- Female subjects with breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for disease-specific chemotherapy
- Confirmed menarche
- ECOG performance status 0-1
- Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders
- Ongoing treatment with GnRHa at baseline
- Direct radiation of the gonads previous or planned (total body irradiation allowed)
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data
- Previous or planned bilateral oophorectomy
- Pregnancy or breastfeeding at time of start of chemotherapy
- Other malignancy diagnosed within the last five years
- Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia
- Known osteoporosis
- Known refractory thrombocytopenia in subjects with acute leukemias
- Known or suspected allergy against triptorelin
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.