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)
Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome [Recruiting]
The purpose of this study is to compare the effectiveness of low dose human chorionic
gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its
endocrine response in patients who had previously failed to ovulate on clomiphen citrate
alone. The investigators will also compare the effectiveness and endocrine response of this
approach with the regimen of adding HMG to clomiphen citrate.
Optimal rhCG(OvidrelŪ) Dose in Poor Responder During IVF and ICSI Cycles [Not yet recruiting]
Choriogonadotropin alfa (OvidrelŪ) 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.
Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel [Recruiting]
The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and
Ovidrel for inducting final follicular maturation and early luteinization in women
undergoing ovulation induction for assisted reproduction treatment
Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders [Not yet recruiting]
In an era of delayed fertility plans, there is increasing need for fertility treatment in
older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to
treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment [Recruiting]
This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh)
agonist to prevent the rise of progesterone during controlled ovarian stimulation for in
vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on
the first day of menses.
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