Clinical trial NCT01718119: Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperovulation Induction for Assisted Reproduction Treatment
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: the efficacy and safety of DA-3803(r-hCG)
timeFrame: about 1 month after ART
Secondary outcomes:
measure: the efficacy of DA-3803(r-hCG)
timeFrame: about 1 month after ART
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Cha Medical school Boondang-Cha hospital
state: Gyeong-Gi Do
city: Seoul
country: Korea, Republic of
facility: Cha Medical school Gangnam-Cha hospital
city: Seoul
country: Korea, Republic of
facility: Kwandong university medical school Cheil hospital
Study officials:
affiliation: Cha Medical school Gangnam-Cha hospital
name: TaeGi Yoon, MD
role: STUDY_CHAIR
affiliation: Cha Medical school Boondang-Cha hospital
name: DongHee Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwandong university medical school Cheil hospital
name: MiKyoung Goong, MD
role: PRINCIPAL_INVESTIGATOR
References: