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

What Was Tested

In this phase 3 trial, researchers set out to test Triptorelin.

Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries.

If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future.

It had two arms (groups): Arm A (triptorelin) (experimental) and Arm B (usual care) (active comparator).

Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.

The registry classes the interventions as drug, other and procedure.

More on the Plan

Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age \< 40 years (exclusive of breast cancer).

Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients.

Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients.

Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to women only aged up to 39 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: \< 40 years of age at the time of enrollment. Patient must be a post-menarchal female and report that their initial menstrual period occurred \> 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.). 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). All patients and/or their parents or legal guardians must sign a written informed consent.

The full record lists 12 inclusion and 10 exclusion criteria; among the exclusions: any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (gy) to the hypothalamus, inclusive of any total body irradiation (tbi); 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).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

The Triptorelin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.

It started in 2025-02-27 with completion listed for 2029-10-30.

It ran at 206 sites in United States (201) and Canada (5).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years (time frame: Up to 2 years post-chemotherapy). Accrual rates of newly diagnosed AYA female cancer patients age < 40 years (time frame: Up to 2 years post-chemotherapy). Anti-mullerian hormone (AMH) levels (time frame: At 2 years post-chemotherapy).

It also tracked 12 secondary outcomes, for example Longitudinal AMH along with other ovarian hormone levels, Estrogen deprivation symptoms: Hot flashes, Estrogen deprivation symptoms: Headaches, Estrogen deprivation symptoms: Vaginal/vulvar symptoms, Estrogen deprivation symptoms: Sexual function and Sexual Health.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.