General Information

Ovidrel is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG).

Ovidrel (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 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.

Recommended dosing/administration

Infertile Women Undergoing Assisted Reproductive Technologies (ART)

• Ovidrel PreFilled Syringe 250 μg should be administered one day following the last dose of the follicle stimulating agent. Ovidrel should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Administration should be withheld in situations where there is an excessive ovarian response, as evidenced by clinically significant ovarian enlargement or excessive estradiol production.

Infertile Women Undergoing Ovulation Induction (OI)

• Ovidrel PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Ovidrel PreFilled Syringe 250 μg should be administered one day following the last dose of the follicle stimulating agent. Ovidrel administration should be withheld in situations where there is an excessive ovarian response, as evidenced by multiple follicular development, clinically significant ovarian enlargement or excessive estradiol production.

Mechanism of Action

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. 

Side Effects

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

Clinical Trial Results

The safety and efficacy of Ovidrel have been examined in three well-controlled studies in women; two studies for assisted reproductive technologies (ART) and one study for ovulation induction (OI). Assisted Reproductive Technologies (ART) The safety and efficacy of Ovidrel 250 μg and Ovidrel 500 μg administered subcutaneously versus 10,000 USP Units of an approved urinary-derived hCG product administered intramuscularly were assessed in a randomized, open-label, multicenter study in infertile women undergoing in vitro fertilization and embryo transfer (Study 7927). The study was conducted in 20 U.S. centers. The primary efficacy parameter in this single-cycle study was the number of oocytes retrieved. 297 patients entered the study, of whom 94 were randomized to receive Ovidrel 250 μg. The number of oocytes retrieved was similar for the Ovidrel and urinary-derived hCG (10,000 USP Units) treatment groups. The efficacy of Ovidrel 250 μg and Ovidrel 500 μg were both found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product and to each other.

For the 33 patients who achieved a clinical pregnancy with Ovidrel 250 μg: 

• Clinical pregnancies not reaching term: 4 (12.1%)
• Live births: 29 (87.9%)
• Singleton: 20 (69.0%)
• Multiple birth: 9 (31.0%)

The safety and efficacy of Ovidrel 250 μg administered subcutaneously versus 5,000 IU of an approved urinary-derived hCG product administered subcutaneously were assessed in a second, randomized, multicenter study in infertile women undergoing in vitro fertilization and embryo transfer (Study 7648). This double-blinded study was conducted in nine centers in Europe and Israel. The primary efficacy parameter in this single-cycle study was the number of oocytes retrieved per patient. 205 patients entered the study, of whom 97 received Ovidrel 250 μg. The efficacy of Ovidrel 250 μg was found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product. 

For the 32 patients who achieved a clinical pregnancy with Ovidrel 250 μg:

• Clinical Pregnancies not reaching term: 6 (18.8%)
• Live births: 26 (81.2%)
• Singleton: 18 (69.2%)
• Multiple birth: 8 (30.8%)

Ovulation Induction (OI)

The safety and efficacy of Ovidrel 250 μg administered subcutaneously versus 5,000 IU of an approved urinary-derived hCG product administered intramuscularly were assessed in a double blind, randomized, multicenter study in anovulatory infertile women (Study 8209) which was conducted in 19 centers in Australia, Canada, Europe and Israel. The primary efficacy parameter in this single-cycle study was the patient ovulation rate. 242 patients entered the study, of whom 99 received Ovidrel 250 μg. The efficacy of Ovidrel 250 μg was found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product. 

• Ovulation Rate: 91 (91.9%)
• Clinical Pregnancy Rate: 22 (22%)

For the 22 patients who had a clinical pregnancy with Ovidrel 250 μg:

• Clinical Pregnancies not reaching term: 7 (31.8%)
• Live births: 15 (68.2%)
• Singleton: 13 (86.7%)
• Multiple birth: 2 (13.3%)