Ovidrel® PreFilled Syringe
(choriogonadotropin alfa injection)
FOR SUBCUTANEOUS USE
Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein consisting of two non-covalently linked subunits - designated (alpha) and (beta) - consisting of 92 and 145 amino acid residues, respectively, with carbohydrate moieties linked to ASN-52 and ASN-78 (on alpha subunit) and ASN-13, ASN-30, SER-121, SER-127, SER-132 and SER-138 (on beta subunit). The primary structure of the (alpha) - chain of r-hCG is identical to that of the (alpha) - chain of hCG, FSH and LH. The glycoform pattern of the (alpha) - subunit of r-hCG is closely comparable to urinary derived hCG (u-hCG), the differences mainly being due to the branching and sialylation extent of the oligosaccharides. The (beta) - chain has both O- and N-glycosylation sites and its structure and glycosylation pattern are also very similar to that of u-hCG.
Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as
fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.
Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel® PreFilled Syringe only if enrolled in an
Primary ovarian failure should be excluded by the determination of gonadotropin levels.
Appropriate evaluation should be performed to exclude pregnancy.
Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel® PreFilled Syringe therapy.
Evaluation of the partner's fertility potential should be included in the initial evaluation.
Published Studies Related to Ovidrel (Choriogonadotropin Alfa)
Recombinant human chorionic gonadotropin (rhCG) in assisted reproductive technology: results of a clinical trial comparing two doses of rhCG (Ovidrel) to urinary hCG (Profasi) for induction of final follicular maturation in in vitro fertilization-embryo transfer. [2001.07]
OBJECTIVE: To compare the efficacy and safety of 250 microg and 500 microg of recombinant hCG with 10,000 U USP of urinary hCG in assisted reproduction technology.
Efficacy of luteinizing hormone activity in patients undergoing in vitro fertilization and treated only with low-dose recombinant choriogonadotropin alfa (Ovidrel) in the late follicular phase. [2006.10]
Ten good prognosis patients underwent IVF with a new ovarian stimulation protocol using only 8 microg of recombinant choriogonadotropin and a GnRH antagonist starting at a 14-mm lead follicle.
Clinical Trials Related to Ovidrel (Choriogonadotropin Alfa)
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation [Not yet recruiting]
This trial is investigating the efficacy and safety of highly purified human chorionic
gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of
final follicular maturation in women undergoing controlled ovarian stimulation
An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART) [Completed]
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).
Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD [Not yet recruiting]
The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when
given in combination with standard immunosuppressive therapy in pediatric and adult patients
with high-risk (Arm 1) or refractory (Arm 2) aGVHD.
Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles [Recruiting]
Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from
genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte
maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been
investigated about its safety and efficacy comparing with urinary hCG, but still the optimal
dose of rhCG is questionable. From former studies, there only have been proven that high
dose of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the
other hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor
responders who cannot easily provoke OHSS. Hence, this study will assess the comparative
efficacy and safety of 250mcg and 500mcg of rhCG in ART treatment cycle.
Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients [Terminated]
The purpose of this study is:
- To assess the neurological outcome in acute ischemic stroke patients treated with
NTx®-265, when compared with patients given a placebo control.
- To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke
Reports of Suspected Ovidrel (Choriogonadotropin Alfa) Side Effects
Ectopic Pregnancy (5),
Ovarian Hyperstimulation Syndrome (3),
Maternal Exposure Before Pregnancy (2),
Multiple Pregnancy (2),
Abortion Spontaneous (1),
Foetal Growth Restriction (1),
Caesarean Section (1), more >>
Page last updated: 2007-02-12