An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART)
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
Summary
With the development of the recombinant gonadotrophins, the use of human source proteins for
the production of hormones has become unnecessary. These proteins, which are found in urinary
preparations, have been thought to cause the local, post-injection adverse events (AEs) in
some subjects.
There has been a demand by physicians for an alternative to urinary products for treatment.
Due to allergies to urinary products, or other personal reasons, subjects were not able or
willing to be treated with proteins of human origin. This study allowed subjects to be
treated with the recombinant human chorionic gonadotropin (r hCG) (free of urinary proteins),
which otherwise would not be possible. The study sponsor used this opportunity to collect
additional safety data on the new recombinant product, (Ovidrel, r-hCG).