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The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and Ovidrel for inducting final follicular maturation and early luteinization in women undergoing ovulation induction for assisted reproduction treatment
This is an single-blind, randomized, comparative multicentric, phase III study to evaluate the safety and efficacy of DA-3803(r-hCG) in comparison with Ovidrel in the induction of final follicle maturation and early luteinization in 180 Korean female subjects undergoing superovulation. The study is organized on an outpatient basis in subjects undergoing assisted reproductive technologies (ART). The subjects are randomized into 2 groups. One group receive DA-3803(r-hCG) 250mcg and the other group receive Ovidrel®(r-hCG)250mcg. Each subject in both groups receives a single injection of hCG when the follicular development was judged to be adequate. Oocytes are retrieved 34-38 hours after r-hCG injection and fertilized in vitro. Not more than 4 embryos are to be replaced. Progesterone is administered daily according to center's normal practice, starting after the oocyte pick up and continuing until appropriate time. The subject is followed up and the treatment outcome (negative pregnancy test or pregnancy) is recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-3803 | Experimental | subjects treated with DA-3803(r-hCG) |
|
| Ovidrel | Active Comparator | subjects treated with Ovidrel(r-hCG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| r-hCG | Drug | r-hCG(250mcg) injection subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| the efficacy and safety of DA-3803(r-hCG) | the number of oocytes retrieved per patient following r-hCG administration, physical examination, clinical laboratory measurements, adverse events, injection-sited reactions, OHSS, number of multiple pregnancies | about 1 month after ART |
| Measure | Description | Time Frame |
|---|---|---|
| the efficacy of DA-3803(r-hCG) | number of patients who received r-hCG with at least one oocyte retrieved, number of oocyte retrieved per number of follicles >10mm diameter on the day of r-hCG, number of mature oocytes, number of 2PN fertilized oocytes, number of 2PN cleaved embryos, implantation rate per embryo transferred, number of biochemical and clinical pregnancies | about 1 month after ART |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TaeGi Yoon, MD | Cha Medical school Gangnam-Cha hospital | Study Chair |
| DongHee Choi, MD | Cha Medical school Boondang-Cha hospital | Principal Investigator |
| MiKyoung Goong, MD | Kwandong university medical school Cheil hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cha Medical school Boondang-Cha hospital | Seongnam | Gyeong-Gi Do | South Korea | |||
| Cha Medical school Gangnam-Cha hospital |
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| Seoul |
| South Korea |
| Kwandong university medical school Cheil hospital | Seoul | South Korea |