Perinatal outcome of pregnancy after GnRH antagonist (ganirelix) treatment during ovarian stimulation for conventional IVF or ICSI: a preliminary report.
BACKGROUND
Gonadotrophin-releasing hormone (GnRH) antagonists have been proven safe and effective, with no adverse effects on offspring in animal studies. Careful study of pregnancy outcome in humans is mandatory.


RESULTS
This preliminary report includes follow-up data of patients treated with the GnRH antagonist, ganirelix, during ovarian stimulation for IVF or ICSI. In total, 333 patients were randomized in a multicentre, double-blind, dose-finding study of ganirelix, at six different doses ranging from 0.0625 to 2 mg. In total, 68 vital intrauterine pregnancies were established that resulted in the birth of 46 singletons, 12 twins and one triplet. Follow-up of the 67 pregnant patients (one subject was lost to follow-up) revealed six miscarriages (9%). Of the 61 subjects with an ongoing pregnancy, two with a singleton pregnancy did not give birth to a live-born infant (one spontaneous abortion in week 19, and one intrauterine death in week 27). The mean gestational age was 39.4 weeks for singleton pregnancies, and 36.6 weeks for multiple pregnancies. In total, 73 infants (33 boys, 40 girls) were born. A birth weight <2500 g was reported for 8.7% and 54.2% of the infants resulting from singleton and twins delivery respectively. One major congenital malformation was diagnosed; a boy with Beckwith-Wiedemann syndrome (exomphalos and macroglossia). Seven minor malformations were reported among five infants.


CONCLUSIONS
In this first follow-up study, the incidence of adverse obstetrical and neonatal outcome was comparable with reported incidences for IVF-embryo transfer pregnancies.
Olivennes
F
F
Hôpital Antoine Béclère, Service de Gynecologie-Obstétrique 157, Clamart, France.
Mannaerts
B
B
Struijs
M
M
Bonduelle
M
M
Devroey
P
P
D000328:Adult; D001724:Birth Weight; D000013:Congenital Abnormalities / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D005307:Fertilization in Vitro; D005865:Gestational Age; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage* / Q000031:analogs & derivatives / Q000037:antagonists & inhibitors* / Q000627:therapeutic use; D006554:Hernia, Umbilical / Q000175:diagnosis; D006801:Humans; D007231:Infant, Newborn; D007744:Obstetric Labor Complications / Q000453:epidemiology; D010062:Ovulation Induction; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology; D011256:Pregnancy Outcome; D018607:Pregnancy Reduction, Multifetal; D011272:Pregnancy, Multiple; D020554:Sperm Injections, Intracytoplasmic; D014310:Triplets; D014427:Twins
D007987:Gonadotropin-Releasing Hormone; C061018:ganirelix