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

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

Study Overview

• Status: Completed
• Conditions: Hyperovulation Induction for Assisted Reproduction Treatment
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Cha Medical school Gangnam-Cha hospital
  • Seoul, Korea, Republic of
    • Kwandong university medical school Cheil hospital
  • Gyeong-Gi Do
    • Seongnam, Gyeong-Gi Do, Korea, Republic of
      • Cha Medical school Boondang-Cha hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the efficacy of DA-3803(r-hCG)	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	about 1 month after ART

Collaborators and Investigators

• Sponsor: Dong-A Pharmaceutical 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

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 5, 2012
• First Submitted That Met QC Criteria: October 27, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: DA3803_HCG_III