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Titolo:
Treatment with the gonadotrophin-releasing hormone antagonist ganirelix inwomen undergoing ovarian stimulation with recombinant follicle stimulatinghormone is effective, safe and convenient: results of a controlled, randomized, multicentre trial
Autore:
Borm, G; Mannaerts, B;
Indirizzi:
NV Organon, Res & Dev, NL-5340 BH Oss, Netherlands NV Organon Oss Netherlands NL-5340 BH & Dev, NL-5340 BH Oss, Netherlands
Titolo Testata:
HUMAN REPRODUCTION
fascicolo: 7, volume: 15, anno: 2000,
pagine: 1490 - 1498
SICI:
0268-1161(200007)15:7<1490:TWTGHA>2.0.ZU;2-M
Fonte:
ISI
Lingua:
ENG
Soggetto:
IN-VITRO FERTILIZATION; SERUM LUTEINIZING-HORMONE; HEALTHY FEMALE VOLUNTEERS; INVITRO FERTILIZATION; PHARMACODYNAMIC CHARACTERISTICS; ANTAGON/ORGALUTRAN-ASTERISK; HYPERSTIMULATION SYNDROME; HUMAN ENDOMETRIUM; MENSTRUAL-CYCLE; GNRH ANTAGONIST;
Keywords:
buserelin; ganirelix; GnRH gonist; GnRH antagonist; ICSI; IVF; ovarian stimulation; recombinant FSH;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
35
Recensione:
Indirizzi per estratti:
Indirizzo: Mannaerts, B NV Organon, Res & Dev, POB 20, NL-5340 BH Oss, Netherlands NVOrganon POB 20 Oss Netherlands NL-5340 BH ss, Netherlands
Citazione:
G. Borm e B. Mannaerts, "Treatment with the gonadotrophin-releasing hormone antagonist ganirelix inwomen undergoing ovarian stimulation with recombinant follicle stimulatinghormone is effective, safe and convenient: results of a controlled, randomized, multicentre trial", HUM REPR, 15(7), 2000, pp. 1490-1498

Abstract

A multicentre, open-label, randomized study of the gonadotrophin-releasinghormone (GnRH) antagonist ganirelix (Orgalutran(R)/Antagon(TM)) was performed in women undergoing ovarian stimulation with recombinant FSH (rFSH: Puregon(R)), The study was designed as a non-inferiority study using a long protocol of buserelin (intranasal) and rFSH as a reference treatment. A totalof 730 subjects was randomized in a treatment ratio of 2:1 (ganirelix:buserelin) using an interactive voice response system which stratified for age,type of infertility and planned fertilization procedure [IVF or intracytoplasmic sperm injection (ICSI)]. The median duration of GnRH analogue treatment was 5 days in the ganirelix group and 26 days in the buserelin group, whereas the median total rFSH dose was 1500 IU and 1800 IU respectively. In addition, in the ganirelix group the mean duration of stimulation was 1 dayshorter. During ganirelix treatment the incidence of LH rises (LH greater than or equal to 10 IU/l) was 2.8% versus 1.3% during rFSH stimulation in the buserelin group. On the day of triggering ovulation by human chorionic gonadotrophin (HCG), the mean number of follicles greater than or equal to 11 mm diameter was 10.7 and 11.8, and the median serum oestradiol concentrations were 1190 pg/ml and 1700 pg/ml in the ganirelix and buserelin groups respectively. The mean number of oocytes per retrieval was 9.1 and 10.4 respectively, whereas the mean number of good quality embryos was 3.3 and 3.5 respectively. The fertilization rate was equal in both groups (62.1%), and the same mean number of embryos (2.2) was replaced. The mean implantation rates were 15.7% and 21.8%, and the ongoing pregnancy rates per attempt were 20.3% and 25.7% in the ganirelix and buserelin groups respectively. Evaluation of all safety data indicated that the ganirelix regimen was safe and well tolerated, The overall incidence of ovarian hyperstimulation syndrome was 2.4% in the ganirelix group and 5.9% in the reference group. The results of this study support a safe, short and convenient treatment regimen of ganirelix, resulting in a good clinical outcome for patients undergoing ovarian stimulation for IVF or ICSI.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/09/20 alle ore 01:49:57