Abstratc fra ESHRE 2003 i
USE OF GANIRELIX FOR RAPID
DOWN-REGULATION BEFORE IVF TREATMENT – A NORDIC MULTI-CENTER TRIAL.
Lars Nilsson, Anders
Nyboe Andersen, Svend Lindenberg, Jon Hausken.
The IVF-units of Sahlgrenska
University Hospital, Goteborg, Sweden, Rigshospitalet and Herlevs Sygehus,
Denmark, and Haugesunds hospital, Norway.
Earlier pilot studies have indicated that GnRH antagonists might be used
for rapid “down regulation” instead of 2-3 weeks of agonist treatment. This
approach may show advantages for poor responders, since a flare up effect
may be created.
To induce luteolysis (primary endpoint) in 90 % of the patients within 7
days of treatment with 0.25 mg of ganirelix sc daily, and to achieve an
acceptable pregnancy rate in a poor responder subsample.
Multicenter, extended pilot study, open.
Material and Methods:
60 cycles in 60 patients, undergoing IVF or ICSI treatment in their second
or third attempt, where the previous cycle had demonstrated a reduced
response to gonadotrophin stimulation, using the long agonist protocol,
defined as 4 or less oocytes harvested after a total FSH-dose of at least 2
000 IU and a starting dose of at least 150 IU of FSH. The women should be
under 40 years, have a BMI below 35 and have a menstrual cycle length
between 23-35 days. Ganirelix was administered in a daily dose of 0.25 mg
for up to 7 days, from 3-5 days before expected menses.
“Luteolysis” was defined as:
absence of a corpus luteum, endometrial thickness of 5 mm or less and no
follicles above 10 mm on ultrasound scan, and a serum estradiol below 0.20
nmol/L, plus menstrual-like bleeding. Stimulation should then commence using
300-400 IU of rec-FSH (Puregon). Ultrasound scanning and estradiol
measurement should be performed from day 6 of stimulation, and daily doses
of ganirelix 0.25 mg reinstituted, when one follicle of 14 mm was detected.
Injection of hCG should be performed when at least one follicle exceeded 17
mm in diameter and follicle puncture performed within 38 hours thereafter.
The interimistic results show that (up to May 2003) 38 patients have started
ganirelix treatment in 3 centers, 36 fulfilled the criteria of luteolysis
and 26 have had a transfer of 1-2 embyos. An additional patient, who was not
down regulated until after 9 days reached transfer. So far, 5 positive
pregnancy tests and 4 ongoing pregnancies have been recorded, but 4 more end
results are not yet ready. One or two other centers may show results in
It can be concluded, although prematurely, that a high proportion (36 out of
38) of patients do reach “luteolysis” by the present criteria within 7 days
of treatment with 0.25 mg ganirelix (median 4 days). The treatment may
constitute a favourable alternative to 2-3 weeks of agonist treatment.