Treatment with the gonadotrophin-releasing hormone antagonist ganirelix in women undergoing ovarian stimulation with recombinant follicle stimulating hormone is effective, safe and convenient: results of a controlled, randomized, multicentre trial. The European Orgalutran Study Group.

What Was Tested

Researchers studied Follicle Stimulating Hormone in this randomized controlled trial publication.

A multicentre, open-label, randomized study of the gonadotrophin-releasing hormone (GnRH) antagonist ganirelix (Orgalutran((R))/Antagon((TM))) was performed in women undergoing ovarian stimulation with recombinant FSH (rFSH: Puregon((R))).

In addition, in the ganirelix group the mean duration of stimulation was 1 day shorter.

Who Took Part

According to the abstract, 730 subjects were involved.

The age groups tagged for this paper are children, teenagers, adults and middle-aged adults, women only.

A total of 730 subjects was randomized in a treatment ratio of 2:1 (ganirelix:buserelin) using an interactive voice response system which stratified for age, type of infertility and planned fertilization procedure [IVF or intracytoplasmic sperm injection (ICSI)].

How the Study Was Run

The researchers set it up as a randomized, open-label and multicenter study.

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

Everyone knew when Follicle Stimulating Hormone was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Running at several centres spread the Follicle Stimulating Hormone study over different clinics and patient groups.

What Was Measured

Topics PubMed links to this paper include Buserelin, Fertility Agents, Female, Follicle Stimulating Hormone, Gonadotropin-Releasing Hormone, Hormone Antagonists, Hormones and Luteinizing Hormone.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Follicle Stimulating Hormone in 730 subjects.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2000 (Human reproduction (Oxford, England)), a journal based in England.

More context: all human trials.