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Using triptorelin to protect ovaries in young cancer patients during chemotherapy

Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer

Phase 3 Interventional Children's Oncology Group · NCT06513962

This study is testing if triptorelin can help protect the ovaries of young cancer patients under 40 during chemotherapy to see if it helps maintain their fertility and overall health later on.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment60 (estimated)
AgesN/A to 39 Years
SexFemale
SponsorChildren's Oncology Group Research network
Drugs / interventionschemotherapy, radiation, cyclophosphamide
Locations193 sites (Birmingham, Alabama and 192 other locations)
Trial IDNCT06513962 on ClinicalTrials.gov

What this trial studies

This phase III trial investigates the effectiveness of triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) under 40 years old who are newly diagnosed with cancer and receiving chemotherapy with alkylating agents. Participants are randomly assigned to receive either triptorelin or no triptorelin before starting chemotherapy. The study aims to measure ovarian reserve through anti-Mullerian hormone (AMH) levels two years after treatment and to assess the long-term reproductive health of participants. Additionally, the trial will evaluate the feasibility of tracking estrogen deprivation symptoms and quality of life among the participants.

Who should consider this trial

Good fit: Ideal candidates are post-menarchal females under 40 years old, newly diagnosed with cancer (excluding breast cancer), and scheduled to receive alkylating agent chemotherapy.

Not a fit: Patients who are over 40 years old or have a history of breast cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of infertility in young cancer patients undergoing chemotherapy.

How similar studies have performed: Previous studies have shown promise in using hormonal treatments to protect ovarian function during chemotherapy, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* \< 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).
* 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.
* For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED.
* 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 Criteria:

* 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.
* Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted 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).

Where this trial is running

Birmingham, Alabama and 192 other locations

+143 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.