Using GnRHa to protect fertility during chemotherapy for young women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Gonadotropin-Releasing Hormone agonist (GnRHa) to preserve fertility in young women undergoing chemotherapy for various cancers, including breast cancer and acute leukemias. Approximately 500 women will be recruited and randomly assigned to receive either the experimental drug triptorelin or a placebo during their chemotherapy treatment. The study employs a double-blind design, ensuring that neither the participants nor the investigators know which treatment is being administered. Participants will be monitored for up to five years post-treatment to assess the long-term effects on fertility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent
* Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy
* Confirmed menarche
* ECOG performance status 0-1
* Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders

Exclusion Criteria:

* 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 low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias
* Known or suspected allergy against triptorelin
* Direct radiation of the gonads previous or planned (TBI allowed)
* Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation

Where it's running

• Karolinska Univeristy Hospital, Breast Centre
  Stockholm, Sweden Recruiting
• Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet
  Stockholm, Sweden Recruiting
• Karolinska University Hospital, Hematology
  Stockholm, Sweden Recruiting
• Karolinska University Hospital, High Specialised Pediatric Medicine
  Stockholm, Sweden Recruiting
• Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth
  Gothenburg, Sweden Not yet recruiting
• Center for Pediatric Oncology, Akademiska Hospital
  Gothenburg, Sweden Not yet recruiting

Study contacts

• Study coordinator: Kenny Rodriguez Wallberg, MD, PhD
• Email: kenny.rodriguez-wallberg@ki.se
• Phone: +46 858580000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.