A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT

What Was Tested

In this not phased trial, researchers set out to test Leuprolide.

However, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (POF), which seriously affect the long-term quality of life of patients.

It had two arms (groups): Leprorelin group (experimental) and Control group (placebo comparator).

Leprorelin was given subcutaneously before each cycle of chemotherapy.

Normal salinewas given subcutaneously before each cycle of chemotherapy.

The registry classes the interventions as drug.

More on the Plan

However, in the process of radiotherapy and chemotherapy before transplantation, the reproductive system is vulnerable to damage, leading to ovarian failure, which leads to infertility and premature ovarian failure (POF), seriously affecting the long-term quality of life of patients.

However, there is a lack of large-scale clinical studies on POF in HSCT.

Therefore, this clinical trial aimed to observe the effect of GnRHa application before transplantation on ovarian function in women of reproductive age after transplantation, so as to provide clinical evidence for whether GnRHa application for fertility function protection.

Who Took Part

200 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Diagnosed with acute leukemia, MDS, lymphoma, multiple myeloma, SAA and other hematological diseases, with the indications for autologous or allogeneic hematopoietic stem cell transplantation. Female, aged 18-45 years. Ovarian function was normal before treatment. Volunteer to participate in clinical research and sign the informed consent form.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: no menstruation before treatment, undergone hysterectomy or ovarian surgery; abnormal sexual development; received radiotherapy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2023-03-01 with completion listed for 2025-10-31.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: POF rate (time frame: three years after transplantation).

It also tracked 5 secondary outcomes, for example acute GVHD rate, chronic GVHD rate, PFS, OS and AEs.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Leuprolide in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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