A Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Final Follicle Maturation and Early Luteinization in Chinese Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)

What Was Tested

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

This was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of final follicle maturation and early luteinization in Chinese female subjects undergoing IVF or ET.

It had two arms (groups): Subjects treated with r-hCG (experimental) and Subjects treated with urinary hCG (active comparator).

Subjects treated with r-hCG.

Subjects treated with urinary hCG.

The registry classes the interventions as drug.

More on the Plan

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

All subjects underwent pituitary down- regulation per each center's normal practice prior to and during stimulation of multiple follicular development.

The subjects were randomized into 2 groups.

Each subject in both groups received a single injection of hCG when the follicular development was judged to be adequate.

Who Took Part

Enrollment: 218 actual participants took part.

It was open to women only.

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

Examples of who could join: Infertility regular ovulatory menstrual cycles;. Early luteal phase serum levels:. Haematology, blood chemistry, urinalysis normal. Both ovaries present. \< 3 previous ART cycles, no ART cycles for 2 menstrual cycles.

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: with a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any previous ivf cycle; any medical condition may interfere with the absorption, distribution, metabolism or excretion of the drug; had previous severe ovarian hyperstimulation syndrome(ohss).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

It started in 2003-12 with completion listed for 2004-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of oocyte retrieved (time frame: 36 hrs after hCG administration).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 218 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.