Subcutaneously administered Repronex in oligoovulatory female patients undergoing ovulation induction is as effective and well tolerated as intramuscular human menopausal gonadotropin treatment.
OBJECTIVE
To determine the efficacy and safety of Repronex SC as compared with Repronex IM and Pergonal IM in patients undergoing ovulation induction.


METHODS
Randomized, open-label, multicenter, parallel group study.


METHODS
Ten academic and private fertility clinics with expertise in ovualtion induction.


METHODS
Premenopausal anovulatory and oligoovulatory females (n = 115) undergoing ovulation induction.


METHODS
Down-regulation with leuprolide acetate followed by up to 12 days of treatment with gonadotropins and hCG administration and luteal phase progesterone support.


METHODS
Percentage of patients ovulating; percentage of cycles with follicular development meeting criteria for hCG administration; number of follicles recruited per cycle meeting hCG criteria; peak serum E(2) levels; rates of chemical, clinical and ongoing pregnancies; adverse events; injection-site pain scores.


RESULTS
There was no statistically significant difference in the percentage of women who ovulated among the treatment groups. However, Repronex SC was significantly more effective than Pergonal IM in producing follicular development in patients who met hCG criteria. There were no significant differences in clinical, ongoing, or continuing pregnancy rates or in multiple pregnancies among the treatment groups. No differences were found in the safety assessments, proportions or seriousness of adverse events or treatment discontinuations. Also, there were no differences between the three treatment groups in patient-recorded scores of injection-site pain or injection-site reactions.


CONCLUSIONS
Repronex SC is as efficacious and well tolerated as Repronex IM or Pergonal IM in ovulation induction. Self-administration of Repronex SC provides a convenient treatment alternative to daily IM injections.
Nichols
J
J
Greenville Hospital, Greenville, North Carolina, USA.
Knochenhauer
E
E
Fein
S H
SH
Nardi
R V
RV
Marshall
D C
DC
D000328:Adult; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008596:Menotropins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D009930:Organic Chemicals; D006080:Ovarian Follicle / Q000187:drug effects / Q000502:physiology; D010062:Ovulation Induction / Q000379:methods*; D012646:Self Administration
D005300:Fertility Agents, Female; D009930:Organic Chemicals; C432248:Repronex; D008596:Menotropins