MedDataX Logo

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

NCT ID: NCT01718119

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperovulation Induction for Assisted Reproduction Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DA-3803

subjects treated with DA-3803(r-hCG)

Group Type EXPERIMENTAL

r-hCG

Intervention Type DRUG

r-hCG(250mcg) injection subcutaneously

Ovidrel

subjects treated with Ovidrel(r-hCG)

Group Type ACTIVE_COMPARATOR

r-hCG

Intervention Type DRUG

r-hCG(250mcg) injection subcutaneously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

r-hCG

r-hCG(250mcg) injection subcutaneously

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

TaeGi Yoon, MD

Role: STUDY_CHAIR

Cha Medical school Gangnam-Cha hospital

DongHee Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Cha Medical school Boondang-Cha hospital

MiKyoung Goong, MD

Role: PRINCIPAL_INVESTIGATOR

Kwandong university medical school Cheil hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cha Medical school Boondang-Cha hospital

Seongnam, Gyeong-Gi Do, South Korea

Site Status

Cha Medical school Gangnam-Cha hospital

Seoul, , South Korea

Site Status

Kwandong university medical school Cheil hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DA3803_HCG_III

Identifier Type: -

Identifier Source: org_study_id