NCT01718119

Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Dong-A Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperovulation Induction for Assisted Reproduction Treatment

Interventions

Type	Name	Description
DRUG	r-hCG	r-hCG(250mcg) injection subcutaneously

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-02-01
• First posted: 2012-10-31
• Last updated: 2013-08-13

Locations

3 sites across 1 country: South Korea