Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial

What Was Tested

The paper reports a study of Triptorelin, published as a clinical study.

Adenomyomectomy is conservative surgery that is now widely applied; however, relapse is a serious problem after the operation.

Chinese Clinical Trial Registry: ChiCTR1800014340.

Who Took Part

PubMed tags the participants as women only.

Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial.

The primary outcome is relapse assessed using a visual analogue scale (VRS) and numeric rating scale (NRS), pictorial blood loss assessment chart (PBAC) score, and the size of the uterus and the lesion as measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI).

How the Study Was Run

The design is described as randomized and multicenter.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

More than one site took part, so the participants came from several places.

The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, adverse events, assessment by the Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels, and anti-Muellerian hormone and so on.

All these indexes are measured at 3, 6, 12, 18, 24, 30, and 36 months after conservative surgery.

What Was Measured

The subject headings attached to it are Adenomyosis, Blood Loss, Surgical, Luteolytic Agents, Magnetic Resonance Imaging, Pregnancy Rate, Quality of Life and Randomized Controlled Trials as Topic.

Author keywords: Adenomyomectomy, Focal adenomyosis, Relapse and Triptorelin acetate.

What This Means in Plain Language

The paper is a randomized and multicenter study of Triptorelin.

Its findings take up roughly 1 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2020 (Trials), a journal based in England.

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