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Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Completed PHASE2, PHASE3 INTERVENTIONAL NCT01160315

Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases. These drugs are definitely associated with premature ovarian failure (POF), resulting in an important decrease of the long-term quality of life and an increase of morbidity. A recent study showed that the patients treated by alkylating agents had a 4.52 fold higher risk to lose their ovarian function compared with those who were treated by other agents. The rate of POF after treatment ranged from 40 to 80%, according to the age of the patients and the total doses administered. Young women who experience POF have to face with the prospects of infertility and to consider years of hormonal replacement therapy. The possibility of minimizing gonadal damage by administering of protective therapy during chemotherapy represents an attractive option for these patients. The aim of this study is to evaluate the protective effect on the ovarian function of the gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data in human are, however, highly controversial.

Interventions

Name: Triptorelin
Type: DRUG
Description: Triptorelin: intramusculAR injection every 3 months
Name: Norethisterone acetate
Type: DRUG
Description: 5 mg/day per os until during chemotherapy

Primary Outcomes

Measure: Premature ovarian failure rate
TimeFrame: 5 years
Description: Primary endpoint is to evaluate the short and long-term efficacy of triptorelin depot plus progestin versus progestin alone to prevent POF induced by chemotherapy treatment. The ovarian function (FSH, E2, Progesterone, and AMH, presence of spontaneous menstrual cycle and pregnancies) will be evaluated every 3 months during the first 6 months after the end of chemotherapy, every 6 months during the next 18 months and once a year during an additional 5 years. All hormonal treatment has to be interrupted 10 days before the blood test.

Trial Information

NCT ID

NCT01160315

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2, PHASE3

Sponsor

Erasme University Hospital

Last Updated

December 15, 2025