The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.

What Was Tested

The trial (phase 4) is built around Goserelin for endometriosis.

In this study of endometriosis patients the researchers compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy.

In both cases they immediately start In Vitro Fertilization (IVF) treatment.

It had two arms (groups): Zoladex (active comparator) and vaporization only (no intervention).

After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.

Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.

The registry classes the interventions as drug.

Who Took Part

120 actual participants took part.

It was open to women only aged from 18 years up to 38 years.

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

Examples of who could join: Laparoscopical vaporization of endometriosis. 1,2, 3e IVF cycle. Endometriosis stage I and II. Younger than 38 years.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: endometriosis cysts; uterine pathology; endocrinological diseases and problems.

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 Goserelin and who got the comparison, which limits bias.

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

Being open-label, the Goserelin study did not mask who received what.

It started in 2012-03 with completion listed for 2014-10.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Metaphase II Cells (MII) (time frame: 3 weeks).

It also tracked 5 secondary outcomes, for example Pregnancy Rate, Good Embryo Quality, Number of Pro Nuclear Cell (2PN) and Number of Cryopreserved Embryos.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Goserelin in 120 people with endometriosis.

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

More context: the Goserelin compound page, Endometriosis research.