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Ovidrel

Clinical Pharmacology
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Clinical Pharmacology

Ovidrel

For the 33 patients who achieved a clinical pregnancy with Ovidrel® 250 µg, the outcomes of the pregnancies are presented in Table 4.

Table 4: Pregnancy Outcomes of r-hCG in ART (Study 7927)


Parameter Ovidrel® 250 µg
(n = 33)
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. The results for the 97 patients who received Ovidrel® 250 µg are summarized in Table 5.

Table 5: Efficacy Outcomes of r-hCG in ART (Study 7648)


Parameter Ovidrel® 250 µg
(n = 97)
Mean number of oocytes retrieved per patient 10.6
Mean number of mature oocytes retrieved per patient 10.1
Mean number of 2 PN fertilized oocytes per patient 5.7
Mean number of 2 PN or cleaved embryos per patient 5.1
Implantation rate per embryo transferred (%) 17.4
Mean mid-luteal serum progesterone levels (nmol/L)* 394
Clinical pregnancy rate per initiated treatment cycle (%)† 33
Clinical pregnancy rate per transfer (%)† 37.6
†Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration)
* nmol/L ÷ 3.18 = ng/mL

For the 32 patients who achieved a clinical pregnancy with Ovidrel® 250 µg, the outcomes of the pregnancies are presented in Table 6.

Table 6: Pregnancy Outcomes of r-hCG in ART (Study 7648)


Parameter Ovidrel® 250 µg
(n = 32)
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. The results of those patients who received Ovidrel® 250 µg are summarized in Table 7.

Table 7: Efficacy Outcomes of r-hCG in OI (Study 8209)


Parameter Ovidrel® 250 µg
(n = 99)
Ovulation Rate 91 (91.9%)
Clinical Pregnancy Rate† 22 (22%)
†Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration.
Brand Name: Ovidrel
Generic Name: Choriogonadotropin Alfa Injection
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