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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01718119
First received: February 5, 2012
Last updated: August 12, 2013
Last verified: August 2013

February 5, 2012
August 12, 2013
February 2012
February 2013   (final data collection date for primary outcome measure)
the efficacy and safety of DA-3803(r-hCG) [ Time Frame: about 1 month after ART ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01718119 on ClinicalTrials.gov Archive Site
the efficacy of DA-3803(r-hCG) [ Time Frame: about 1 month after ART ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hyperovulation Induction for Assisted Reproduction Treatment
Drug: r-hCG
r-hCG(250mcg) injection subcutaneously
  • Experimental: DA-3803
    subjects treated with DA-3803(r-hCG)
    Intervention: Drug: r-hCG
  • Active Comparator: Ovidrel
    subjects treated with Ovidrel(r-hCG)
    Intervention: Drug: r-hCG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
Not Provided
February 2013   (final data collection date for primary outcome measure)

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
Female
20 Years to 38 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01718119
DA3803_HCG_III
No
Dong-A ST Co., Ltd.
Dong-A ST Co., Ltd.
Not Provided
Study Chair: TaeGi Yoon, MD Cha Medical school Gangnam-Cha hospital
Principal Investigator: DongHee Choi, MD Cha Medical school Boondang-Cha hospital
Principal Investigator: MiKyoung Goong, MD Kwandong university medical school Cheil hospital
Dong-A ST Co., Ltd.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP