A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

What Was Tested

The trial (phase 3) is built around Triptorelin.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Ganirelix.

Triptorelin.

The registry classes the interventions as drug.

Who Took Part

259 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

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

Examples of who could join: Females of infertile couples for whom COS and IVF or ICSI is indicated. Body mass index between 18 and 29 kg/m2. Willing and able to give written informed consent.

The full record lists 3 inclusion and 18 exclusion criteria; among the exclusions: more than three previous cos cycles for assisted reproduction since last established ongoing pregnancy (if applicable); history of no or low ovarian response to fsh/human menopausal gonadotropin (hmg) treatment; less than 2 ovaries or any other ovarian abnormality including endometrioma.

How the Study Was Run

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

Because people in this Triptorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Triptorelin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.

It started in 2007-05 with completion listed for 2008-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met (time frame: At completion of ovarian stimulation; maximally after 18 days of recFSH administration).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 259 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Triptorelin compound page, all human trials.