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Titolo:
A DOUBLE-BLIND, RANDOMIZED, DOSE-FINDING STUDY TO ASSESS THE EFFICACYOF THE GONADOTROPIN-RELEASING-HORMONE ANTAGONIST GANIRELIX (ORG-37462) TO PREVENT PREMATURE LUTEINIZING-HORMONE SURGES IN WOMEN UNDERGOING OVARIAN STIMULATION WITH RECOMBINANT FOLLICLE-STIMULATING-HORMONE (PUREGON((R)))
Autore:
MANNAERTS B; DEVROEY P; ABYHOLM T; DIEDRICH K; HILLENSJO T; HEDON B; ITSKOVITZELDOR J; KAHN J; NAETHER O; OLIVENNES F; PAVLOU S; TARLATZIS B; WESTERGAARD L; VANDERHEIJDEN B; COELINGH H;
Indirizzi:
NV ORGANON,CLIN DEV DEPT,SCI DEV GRP,POB 20 NL-5340 BH OSS NETHERLANDS UNIV BRUSSELS,ACAD HOSP BRUSSELS BELGIUM NATL HOSP NORWAY,KVINNEKLINIKKEN OSLO NORWAY UNIV LUBECK D-2400 LUBECK GERMANY ACAD HOSP ROTTERDAM DIJKZIGT NL-3000 DR ROTTERDAM NETHERLANDS CARLANDERSKA SJUKHUSET,FERTILITETS CENTRUM GOTENBORG SWEDEN HOP ARNAUD VILLENEUVE MONTPELLIER FRANCE RAMBAM MED CTR HAIFA ISRAEL FERTIL CLIN CICONIA COPENHAGEN DENMARK WEISE & PARTNER,GEMEINSCHAFTSPRAXIS LEIDENBERGER HAMBURG GERMANY HOP ANTOINE BECLERE CLAMART FRANCE MITERA FERTIL & IVF UNIT ATHENS GREECE ODENSE HOSP ODENSE DENMARK
Titolo Testata:
Human reproduction (Oxford. Print)
fascicolo: 11, volume: 13, anno: 1998,
pagine: 3023 - 3031
SICI:
0268-1161(1998)13:11<3023:ADRDST>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
IN-VITRO FERTILIZATION; HUMAN MENOPAUSAL GONADOTROPIN; GNRH ANTAGONIST; NAL-GLU; PREOVULATORY FOLLICLES; MULTIPLE COMPARISONS; CETRORELIX; HYPERSTIMULATION; SECRETION; OVULATION;
Keywords:
GNRH ANTAGONIST GANIRELIX; IVF; OVARIAN STIMULATION; RECOMBINANT FSH; LH SURGE PREVENTION;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
35
Recensione:
Indirizzi per estratti:
Citazione:
B. Mannaerts et al., "A DOUBLE-BLIND, RANDOMIZED, DOSE-FINDING STUDY TO ASSESS THE EFFICACYOF THE GONADOTROPIN-RELEASING-HORMONE ANTAGONIST GANIRELIX (ORG-37462) TO PREVENT PREMATURE LUTEINIZING-HORMONE SURGES IN WOMEN UNDERGOING OVARIAN STIMULATION WITH RECOMBINANT FOLLICLE-STIMULATING-HORMONE (PUREGON((R)))", Human reproduction (Oxford. Print), 13(11), 1998, pp. 3023-3031

Abstract

A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon(R)) toestablish the minimal effective dose preventing premature luteinizinghormone (LH) surges during ovarian stimulation. For ovarian stimulation, rFSH was given in a fixed daily dose of 150 IU for 5 days from days 2 to 6 of the menstrual cycle. From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administeredonce daily by s.c. injection, and the rFSH dose was adjusted depending on ovarian response. The lowest (0.0625 mg) and highest (2.0 mg) dose groups were terminated prematurely on the advice of an external independent advisory committee. Serum Org 37462 concentrations increased in a linear dose-proportional manner, whereas serum LH and increases ofoestradiol fell with increasing Org 37462 dose. During Org 37462 treatment, serum LH concentrations greater than or equal to 10 IU/l were observed in the lowest dose groups with incidences of 16% (0.0625 mg), 9% (0.125 mg) and 1.4 % (0.25 mg), On the day of HCG, the number of follicles greater than or equal to 11, greater than or equal to 15 and greater than or equal to 17 mm were similar in the six dose groups, whereas serum oestradiol concentrations were highest in the 0.0625 mg group (1475 pg/ml) and lowest in the 2 mg group (430 pg/ml), The median daily dose of rFSH was between 150 and 183 IU and the overall median duration of Org 37462 treatment was similar to 5 days in the six treatment groups. Overall, Org 37462 treatment appeared to be safe and well tolerated. The mean number of recovered oocytes and good-quality embryos was similar in all dose groups and ranged from 8.6 to 10.0 and 2.5 to 3.8, respectively. The mean number of replaced embryos in the different dose groups ranged from 2.3 to 2.7, The implantation rate was highest in the 0.25 mg group (21.9%) and lowest in the 2 mg group (1.5%). The early miscarriage rates (first 6 weeks after embryo transfer) were11.9 and 13% in the 1 and 2 mg group respectively, whereas in the other dose groups this incidence was zero (0.0625%) up to a maximum of 3.7% (0.5 mg group). The vital pregnancy rate (with heart activity) at 5-6 weeks after embryo transfer was highest in the 0.25 mg group, i.e. 36.8% per attempt and 40.3% per transfer, and resulted in an ongoing pregnancy rate 12-16 weeks after embryo transfer of 33.8% per attempt and 37.1% per transfer. In conclusion, a daily dose of 0.25 mg Org 37462 prevented LH surges during ovarian stimulation and resulted in a good clinical outcome.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 21/09/20 alle ore 08:56:49