Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel
Information source: Dong-A ST Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperovulation Induction for Assisted Reproduction Treatment
Intervention: r-hCG (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Dong-A ST Co., Ltd. Official(s) and/or principal investigator(s): TaeGi Yoon, MD, Study Chair, Affiliation: Cha Medical school Gangnam-Cha hospital DongHee Choi, MD, Principal Investigator, Affiliation: Cha Medical school Boondang-Cha hospital MiKyoung Goong, MD, Principal Investigator, Affiliation: Kwandong university medical school Cheil hospital
Summary
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: the efficacy and safety of DA-3803(r-hCG)
Secondary outcome: the efficacy of DA-3803(r-hCG)
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
Minimum age: 20 Years.
Maximum age: 38 Years.
Gender(s): Female.
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
Locations and Contacts
Cha Medical school Gangnam-Cha hospital, Seoul, Korea, Republic of
Kwandong university medical school Cheil hospital, Seoul, Korea, Republic of
Cha Medical school Boondang-Cha hospital, Seongnam, Gyeong-Gi Do, Korea, Republic of
Additional Information
Starting date: February 2012
Last updated: August 12, 2013
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