NCT05328258Not yet recruitingPhase 3
ProFertil
A phase III Randomized Double-Blinded Placebo-Controlled Study of Use of GnRHa during Chemotherapy for Fertility Protection of Young Women and Teenagers with Cancer - ProFertil
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 14 Oct 2024
- Start date
- 1 Oct 2022
- Lead sponsor
- Karolinska University Hospital
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT05328258
- EU CT number
- 2024-518977-32-00
- EudraCT number
- 2020-004780-71
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing treatment with GnRHa at baseline
- Direct radiation of the gonads previous or planned (total body irradiation allowed)
- Previous or planned bilateral oophorectomy
- Pregnancy or breastfeeding at time of start of chemotherapy
- Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia
Other illness
- Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data
- Other malignancy diagnosed within the last five years
- Known or suspected allergy against triptorelin
Other
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Known osteoporosis
- Known refractory thrombocytopenia in subjects with acute leukemias
Who the study is looking for
- 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
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Not yet recruiting |
| Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Not yet recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Not yet recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Not yet recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Not yet recruiting |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Not yet recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Not yet recruiting |
| Soedersjukhuset AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Not yet recruiting |
| Capio S:t Goerans Sjukhus AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Not yet recruiting |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Not yet recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.