Use of GnRHa During Chemotherapy for Fertility Protection

What Was Tested

The trial (phase 3) is built around Triptorelin for female fertility.

Many cytotoxic drugs may harm the fertility of young women treated for cancer.

The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can preserve the fertility of young female cancer subjects.

Approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment.

It had two arms (groups): Arm A: Triptorelin (experimental) and Arm B: Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 500 planned participants were the target.

It was open to women only aged from 14 years up to 42 years.

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

Examples of who could join: 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. ECOG performance status 0-1. Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: previous or planned bilateral oophorectomy; pregnancy or breastfeeding at time of start of chemotherapy; other malignancy diagnosed within the last five years.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind 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.

Neither the female fertility participants nor the staff measuring them knew who was on Triptorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2023-03-31 with completion listed for 2028-01-01.

It ran at 17 sites in Sweden (17).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Anti-Müllerian Hormone (AMH) levels in women with breast cancer (time frame: 12 months after end of gonadotoxic chemotherapy and study drug treatment).

It also tracked 19 secondary outcomes, for example Anti-Müllerian Hormone (AMH) levels in women with acute leukemias, lymphomas and sarcomas, Changes in ovarian reserve with or without GnRHa by longitudinal observation of AMH levels, Impact of body mass index (BMI) (Kg/m2) on changes in ovarian reserve with or without GnRHa, Impact of use of contraceptives (yes/no) in changes of ovarian reserve with or without GnRHa, Impact of endocrine adjuvant therapy (yes/no) in changes of ovarian reserve with or without GnRHa and The effect of GnRHa with or without GnRHa on ovarian blood supply.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 500 people with female fertility.

With 500 participants it is a large trial for this field.

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

More context: the Triptorelin compound page, Female fertility research.