Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Triptorelin.

It had two arms (groups): Triptorelin (GnRHa) + Chemotherapy (experimental) and Chemotherapy alone (no intervention).

Patient having a chemotherapy without drug injection for fertility preservation.

The registry classes the interventions as drug.

More on the Plan

Sample size and design One Hundred and sixty (160) patients will be included in this study in order to ensure at least 128 patients who will complete the study.

Analysis populations The main analysis will be an intention-to-treat (ITT) analysis, which will be performed on all the randomized patients with a value of the main criterion of judgment (AMH level at M24).

A per-protocol (PP) analysis will also be performed, as a secondary analysis, excluding patients with major protocol deviation defined a priori. 3.

Primary criteria The value of AMH level at month 24will be compared between the two treatment groups using a test t of Student if AMH values are normally distributed and a non-parametric Wilcoxon test if not.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to women only aged from 12 years up to 25 years.

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

Examples of who could join: Female aged 12 to 25 years. Puberty Tanner 2 or more. Diagnosis of cancer: Sarcoma, Ewing, Osteosarcoma, Lymphoma. Before starting any chemotherapy. Covered by a medical insurance.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: planned brain or pelvic radiotherapy; planned stem cell transplantation; having already received chemotherapy with alkylating agents.

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 2016-11-23 with completion listed for 2021-02.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Variation in AMH serum levels between both groups (time frame: at 24 months).

It also tracked 8 secondary outcomes, for example Number of patients with AMH serum levels < 5th percentile in each group, Intra-patient variation in AMH serum levels between groups, Antral Follicular Count (AFC) on ultrasound between the 2 groups, Delay of resumption of menses between the 2 groups, Levels of markers of ovarian reserve: AMH, Follicle-stimulating hormone (FSH), Estradiol between groups and Pregnancy rate in the 2 groups.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Triptorelin in 11 people.

Its size is small, so on its own it can only give an early look.

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

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