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 below.
Results with Ovidrel®
The efficacy of Ovidrel® 250 μg was found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product.
Efficacy Outcomes of r-hCG in OI (Study 8209)
Ovidrel® 250 μg (n=99)
|Clinical Pregnancy Rateî||22 (22%)|
îClinical 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.
For the 22 patients who had a clinical pregnancy with Ovidrel® 250 μg, the outcome of the pregnancy is presented in Table 8.
Pregnancy Outcomes of r-hCG in OI (Study 8209)
Ovidrel® 250 μg (n=22)
|Clinical Pregnancies not reaching term||(31.8%)|
|Live births||15 (68.2%)|
|Multiple birth||2 (13.3%)|