Ovidrel (Choriogonadotropin Alfa) - Summary

OVIDREL SUMMARY

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 in vitro 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.

1. 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 in vitro fertilization program.
2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
3. Appropriate evaluation should be performed to exclude pregnancy.
4. 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.
5. Evaluation of the partner's fertility potential should be included in the initial evaluation.

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NEWS HIGHLIGHTS

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.

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Clinical Trials Related to Ovidrel (Choriogonadotropin Alfa)

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]

Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome [Not yet 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.

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.

Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-Stimulating Hormone (FSH) for In Vitro Fertilisation [Recruiting]
The purpose of this trial is to study whether addition of different doses of human chorionic gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve the number of top-quality embryos.

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