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.
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
Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles [Recruiting]
The purpose of this study is to possibly further improve the clinical outcome and explore
the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin)
in GnRH antagonist IVF/ICSI cycles
hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle [Completed]
The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the
receptivity of the endometrium and the embryo quality. The effects of human chorionic
gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was
shown to up-regulate gene expression during the differentiation of human endometrial stromal
cells into decidua. The aim of our study was to assess the benefit of hCG supplementation
throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.
Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction [Active, not recruiting]
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