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Brief Title: Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure
Official Title: A Prospective Open Randomized Trial on the Efficacy of Gonadotropin-releasing Hormone Agonist Depot-Triptorelin- to Prevent Chemotherapy Induced Premature Ovarian Failure in Lymphoma Patients.
Study ID: NCT01160315
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Algemeen Ziekenhuis Stuivenberg, Antwerpen, , Belgium
AZ St Jan, Brugges, , Belgium
Bordet, Brussels, , Belgium
Erasme Hospital, Brussels, , Belgium
AZ-VUB, Brussels, , Belgium
St Luc University, Brussels, , Belgium
CHRU Lille, Lille, , Belgium
CHU Dijon, Dijon, , France
CHU Nancy, Nancy, , France
Henry-Mondor Hospital, Paris-Creteil, , France
Hôpital Hotel Dieu, Paris, , France
St Louis Hospital, Paris, , France
CHU St Antoine, Paris, , France
Centre Henri Beckerel, Rouen, , France
Instituto Europeo di oncologia, Milano, , Italy
Name: Yvon Englert, MD, PhD
Affiliation: Erasme hospital
Role: STUDY_DIRECTOR