Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles

What Was Tested

In this phase 4 trial, researchers set out to test Buserelin.

It had four arms (groups): A (experimental), B (active comparator), C (experimental) and D (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 384 actual participants took part.

It was open to women only aged from 20 years up to 39 years.

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

Examples of who could join: Patient complying with the conditions for IVF or ICSI treatment. Female age over 20 years and under 40 years. Normal regular cycle and patients with oligomenorrhea. BMI \> 18 and \< 35. Each patient contributes with one cycle only.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: patients with \> 25 follicles on the day of triggering ovulation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Buserelin 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.

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

It started in 2009-01 with completion listed for 2011-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Frequency of Moderate to Severe OHSS (time frame: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test).

It also tracked 1 secondary outcome, for example Pregnancy Rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Buserelin in 384 people.

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

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