Infertility Clinical Trial
Official title:
An Open, Randomized, Comparative Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Final Follicle Maturation and Early Luteinization in Chinese Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
This was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of final follicle maturation and early luteinization in Chinese female subjects undergoing IVF or ET.
This was an open, randomized, comparative multicentric, phase III study to evaluate the
safety and efficacy of rhCG in comparison with urinary hCG in the induction of final
follicle maturation and early luteinization in 200 Chinese female subjects undergoing
superovulation. The study was organized on an outpatient basis in subjects undergoing
assisted reproductive technologies (ART). All subjects underwent pituitary down- regulation
per each center's normal practice prior to and during stimulation of multiple follicular
development. The subjects were randomized into 2 groups. One group received rhCG 250mcg and
the other group received urinary hCG (Profasi®) 10,000IU. Each subject in both groups
received a single injection of hCG when the follicular development was judged to be
adequate. Oocytes were retrieved 36-38 hours after the hCG injection and fertilized in
vitro. Not more than 3 embryos or 2 blastocysts were to be replaced. Progesterone was
administered daily according to center's normal practice, starting after the oocyte pick up
and continuing until a negative pregnancy test or for the first 3 weeks of pregnancy if the
subject was pregnant. The subject was followed up and the treatment outcome (negative
pregnancy test or pregnancy) was recorded.
A phase I sub-study to evaluate the pharmacokinetics of single subcutaneous (s.c.)
administrations of rhCG was conducted on 24 healthy Chinese female subjects in China. The
subjects were randomized into 3 groups. Each group received a single dose of 250mcg or
500mcg or 750 mcg of rhCG. Blood samples were collected at predetermined intervals after the
injection. Human chorionic gonadotropin serum levels were measured with the Serono MAIAclone
and the in vitro bioassay MA-10. Safety was assessed by the incidence and severity of
adverse events (AEs), including multiple pregnancy and ovarian hyperstimulation syndrome
(OHSS) and significant changes in laboratory values.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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