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

What Was Tested

This registered phase 3 trial tested hCG (human chorionic gonadotropin).

It had two arms (groups): DA-3803 (experimental) and Ovidrel (active comparator).

Subjects treated with DA-3803(r-hCG).

Subjects treated with Ovidrel(r-hCG).

The registry classes the interventions as drug.

More on the Plan

The study is organized on an outpatient basis in subjects undergoing assisted reproductive technologies (ART).

The subjects are randomized into 2 groups.

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.

Who Took Part

180 actual participants took part.

It was open to women only aged from 20 years up to 38 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Infertility regular ovulatory menstrual cycles : 25\~35days. 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.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: 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).

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether hCG (human chorionic gonadotropin) was given.

Those kept unaware of assignments: participant.

It started in 2012-02 with completion listed for 2013-02.

It ran at 3 sites in South Korea (3).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 180 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.