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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

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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

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Detailed Description

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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

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Hyperovulation Induction for Assisted Reproduction Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

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r-hCG

r-hCG(250mcg) injection subcutaneously

Intervention Type DRUG

Eligibility Criteria

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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