Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel
DA-3803
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
1 other identifier
interventional
180
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 5, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedAugust 13, 2013
August 1, 2013
1 year
February 5, 2012
August 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
the efficacy of DA-3803(r-hCG)
about 1 month after ART
Study Arms (2)
DA-3803
EXPERIMENTALsubjects treated with DA-3803(r-hCG)
Ovidrel
ACTIVE COMPARATORsubjects treated with Ovidrel(r-hCG)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cha Medical school Boondang-Cha hospital
Seongnam, Gyeong-Gi Do, South Korea
Cha Medical school Gangnam-Cha hospital
Seoul, South Korea
Kwandong university medical school Cheil hospital
Seoul, South Korea
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2012
First Posted
October 31, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2013
Last Updated
August 13, 2013
Record last verified: 2013-08