Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Phase III Clinical Trial Comparing the Efficacy and Safety of DA-3803(Recombinant Human Chorionic Gonadotrophin) and Ovidrel for Inducting Final Follicular Maturation and Early Luteinization in Women Undergoing Ovulation

Conditions
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Hyperovulation Induction for Assisted Reproduction Treatment

Intervention / Treatment
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* Drug: r-hCG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertility regular ovulatory menstrual cycles : 25 35days BMI<=30kg/m2 Early follicular phase serum levels are normal : FSH, LH, prolactin, testosterone Both ovaries present and clinically normal uterine cavity < 3 previous ART cycles, no ART cycles for 2 menstrual cycles semen analysis and ART are possible informed couple consent Exclusion Criteria: With a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any previous ART cycle Had previous severe ovarian hyperstimulation syndrome(OHSS) Polycystic ovarian syndrome(PCOS) Extra-uterine pregnancy within the last 3 months A clinically significant uncontrolled endocrine diseases, chronic cardiovascular disorders, hepatic, pulmonary and renal diseases Known allergy,hypersensitivity or contraindication to FSH, hCG, progesterone and GnRH antagonists medication with human gonadotrophin preparations(FSH, LH, hCG) within 2 months participation in another clinical trial within 1 month

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-3803<br>subjects treated with DA-3803(r-hCG) | Drug: r-hCG<br>* r-hCG(250mcg) injection subcutaneously<br>|
| Active Comparator: Ovidrel<br>subjects treated with Ovidrel(r-hCG) | Drug: r-hCG<br>* r-hCG(250mcg) injection subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |