Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy

Plain-language guide to NCT02779387: not phased randomized trial of Goserelin, endometriosis, 1184 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02779387
Phase: not phased
Status: status unknown
Start: 2016-05
Completion (planned or actual): 2020-05
Participants: 1184 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Infertility Associated With Endometriosis
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Goserelin for endometriosis.

This study is a multicenter, randomized-control-trial.

Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a.

It had two arms (groups): GnRH-a (experimental) and non GnRH-a (no intervention).

Patients treated with GnRH-a after surgery and Outpatient guidance .

Patients treated with outpatient guidance only.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1184 planned participants were the target.

It was open to women only aged from 20 years up to 35 years.

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

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: male factor causes infertility; hydrosalpinx or salpingemphraxis; uterine malformation.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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 2016-05 with completion listed for 2020-05.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cumulative pregnancy rate (time frame: 18 month after surgery). Time interval between surgery and natural pregnancy (time frame: 18 month after surgery). miscarriage rate (time frame: 18 month after surgery).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Goserelin in 1184 people with endometriosis.

With 1184 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, Endometriosis research.

Our Notes on the Compound

Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.