Ovidrel (gonadotropin, chorionic human recombinant)

Ovidrel has been approved 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. 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. (From FDA Label) It is available by prescription only and is in an injectable formulation.

Two assisted reproductive technologies (ART) studies were held to evaluate the safety and efficacy of Ovidrel at two dosage levels, 250mcg and 500mcg. The drug was administered subcutaneously in a randomized, open-label, 20 center study to infertile women undergoing in vitro fertilization and embryo transfer in the U.S.. 297 patients entered the study, 94 were randomized to receive Ovidrel 250mcg. The primary efficacy parameter was the number of oocytes retrieved. This number was similar for the Ovidrel and urinary-derived hCG treatment groups. Efficacy for Ovidrel 250mcg and Ovidrel 500mcg were both found to be clinically and statistically equivalent to each other and to the urinary-derived hCG treatment group.

Ovidrel is contraindicated in patients who have shown:

• prior hypersensitivity to hCG preparations or one of their excipients
• primary ovarian failure
• uncontrolled thyroid or adrenal dysfunction
• uncontrolled organic intracranial lesion such as a pituitary tumor
• abnormal uterine bleeding of undetermined origin
• ovarian cysts
• sex hormone dependent tumors of the reproductive tract and accessory organs
• pregnancy

Common side effects of Ovidrel include, but are not limited to:

• injection site inflammation
• flatulence
• diarrhea
• hiccup
• ectopic pregnancy
• breast pain
• intermenstrual bleeding
• vaginal hemorrhage
• cervical lesion
• leukorrhea
• ovarian hyperstimulation
• uterine disorders
• vaginitis
• body and back pain
• fever
• dizziness
• headache
• hot flashes
• paraesthesias
• rash
• emotional lability
• insomnia
• upper respiratory tract infection
• urinary tract infection
• cough
• dysuria
• urinary incontinence
• albuminuria
• cardiac arrhythmia
• genital herpes
• leukocytosis
• heart murmur
• cervical carcinoma

The physicochemical, immunological, and biological activities of recombinant hCG are comparable to those of placental and human pregnancy urine-derived hCG. Choriogonadotropin alfa stimulates late follicular maturation and resumption of oocyte meiosis, and initiates rupture of the pre-ovulatory ovarian follicle. Choriogonadotropin alfa, the active component of Ovidrel, is an analogue of Luteinizing Hormone (LH) and binds to the LH/hCG receptor of the granulosa and theca cells of the ovary to effect these changes in the absence of an endogenous LH surge. In pregnancy, hCG, secreted by the placenta, maintains the viability of the corpus luteum to provide the continued secretion of estrogen and progesterone necessary to support the first trimester of pregnancy. Ovidrel is administered when monitoring of the patient indicates that sufficient follicular development has occurred in response to FSH treatment for ovulation induction. (From FDA Label)

Ovidrel is capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Ovarian enlargement which may be accompanied by abdominal distention or pain may occur and usually diminishes without treatment within two or three weeks.

OHSS is different from ovarian enlargement. It may become very serious and may require hospitalization. Early warning signs for OHSS include:

• severe pelvic pain
• nausea
• vomiting
• weight gain

Other symptoms that have been associated with OHSS include:

• abdominal pain
• abdominal distension
• nausea
• vomiting
• diarrhea
• severe ovarian enlargement
• weight gain
• dyspnea
• oliguria

OHSS may become more serious if the patient is pregnant, therefore follow-up after treatment is required. Reports of multiple births have been associated with Ovidrel. It is not known if this drug is excreted in human breast milk and there was some evidence in animal studies of fetal death and impaired parturition.