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
  Purpose

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


Condition Intervention Phase
Hyperovulation Induction for Assisted Reproduction Treatment
Drug: r-hCG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 180
Study Start Date: February 2012
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-3803
subjects treated with DA-3803(r-hCG)
Drug: r-hCG
r-hCG(250mcg) injection subcutaneously
Active Comparator: Ovidrel
subjects treated with Ovidrel(r-hCG)
Drug: r-hCG
r-hCG(250mcg) injection subcutaneously

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718119

Locations
Korea, Republic of
Cha Medical school Boondang-Cha hospital
Seongnam, Gyeong-Gi Do, Korea, Republic of
Cha Medical school Gangnam-Cha hospital
Seoul, Korea, Republic of
Kwandong university medical school Cheil hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01718119     History of Changes
Other Study ID Numbers: DA3803_HCG_III
Study First Received: February 5, 2012
Last Updated: August 12, 2013
Health Authority: South Korea: Food and Drug Administration

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014