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

Phase 3

Completed

• Conditions: Hyperovulation Induction for Assisted Reproduction Treatment
• Interventions: Drug: r-hCG

• Registration Number: NCT01718119
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-05
• Study First Submitted QC: 2012-10-27
• Study First Posted: 2012-10-31
• Primary Completion: 2013-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-3803	r-hCG	subjects treated with DA-3803(r-hCG)
Ovidrel	r-hCG	subjects treated with Ovidrel(r-hCG)

Primary Outcome Measures

Name	Time	Method
the efficacy and safety of DA-3803(r-hCG)	about 1 month after ART	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

Secondary Outcome Measures

Name	Time	Method
the efficacy of DA-3803(r-hCG)	about 1 month after ART	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

Trial Locations

Locations (3)

Cha Medical school Boondang-Cha hospital; 🇰🇷 Seongnam, Gyeong-Gi Do, Korea, Republic of

Cha Medical school Gangnam-Cha hospital; 🇰🇷 Seoul, Korea, Republic of

Kwandong university medical school Cheil hospital; 🇰🇷 Seoul, Korea, Republic of