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Triptorelin for Ovarian Protection in Young Cancer Patients

This study is looking at whether a drug called triptorelin can help protect the ovaries of adolescents and young adults (AYAs) with cancer who are receiving chemotherapy. Chemotherapy, especially with certain drugs called alkylating agents, can sometimes damage the ovaries, making it hard to get pregnant later. Triptorelin works by temporarily pausing ovarian activity, which might shield them from chemotherapy's effects. After triptorelin leaves the body (about 6 months), the ovaries are expected to resume normal function. We want to see if triptorelin can help preserve ovarian function, measured by hormone levels, up to two years after chemotherapy. This study is for women under 40 who have been recently diagnosed with certain cancers, excluding breast cancer.

Study design
This is an interventional study planning to enroll 60 female participants. Participants will be randomly assigned to either receive triptorelin or not, in addition to their standard chemotherapy.
What's involved
You would receive standard chemotherapy, potentially triptorelin injections, and have blood samples collected. You may also complete surveys and have your electronic health records reviewed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to two years after chemotherapy to measure hormone levels and other outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06513962

Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

Recruiting
PHASE3Up to 39InterventionalPrevention
Children's Oncology Group
~60 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Best PracticeBiospecimen CollectionElectronic Health Record ReviewSurvey AdministrationTriptorelin Pamoate

At a glance

Recruiting sites
196 of 206 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years
Measured over Up to 2 years post-chemotherapy
+2 more outcomes measured

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

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Where it's being run

206 sites across 44 states
Illinois26
Missouri22
Michigan18
Iowa17
Florida13
Wisconsin10
California9
Delaware8

Study leadership

  • Eric J Chow · PRINCIPAL_INVESTIGATOR · Children's Oncology Group

Who to contact

Site Public Contact
[email protected]
205-638-9285
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\< 40 years of age at the time of enrollment
Newly diagnosed with first cancer, exclusive of breast cancer.
Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC).
Expected cumulative cyclophosphamide equivalent dose (CED):
For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.
For patients ≥ 20 years of age and \< 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.
For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group.
The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.
All patients and/or their parents or legal guardians must sign a written informed consent.
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion

Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment.
Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).

What this trial measures

  • Number of enrollments of newly diagnosed AYA female cancer patients age < 40 yearsUp to 2 years post-chemotherapy

    Number of enrollments by the end of the DOD funded grant period, and ideally prior to Year 4 to enable greater duration of follow-up time. Will help determine if a larger efficacy study can be successfully completed as a cross network trial in a reasonable funding period.

  • Accrual rates of newly diagnosed AYA female cancer patients age < 40 yearsUp to 2 years post-chemotherapy

    Accrual rates of newly diagnosed AYA female cancer patients age \< 40 years. Over the second half of the funding period, demonstrate a positive trajectory in accrual rates that provides data to inform future funding proposals that would seek to complete the overall larger study within a typical 5-year funding period.

  • Anti-mullerian hormone (AMH) levelsAt 2 years post-chemotherapy

    AMH values will be examined to confirm that the combined variability of AMH in both arms is consistent with our a priori assumptions.