Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

What Was Tested

The trial (phase 4) is built around Leuprolide.

It had two arms (groups): GnRH analog alone (active comparator) and Aromatase inhibitor plus GnRH analog (experimental).

Control group treated with GnRH analog alone.

Experimental group treated with aromatase inhibitor plus GnRH analog.

The registry classes the interventions as drug.

More on the Plan

The investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and uterine myomas a combined therapy with Aromatase inhibitor plus GnRH analog.

With this study the investigators want evaluate which is the best way to treat adenomyosis in order to obtain a higher pregnancy rate in women with symptomatic adenomyosis undergoing IVF who failed a previous IVF attempt.

Who Took Part

The registry lists 300 planned participants were the target.

It was open to women only aged from 30 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women with healty conditions. Recurrent implantation failure.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: presence of systemic diseases.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Leuprolide 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.

Blinding on both sides kept the participants and researchers unaware of who received Leuprolide.

Those kept unaware of assignments: participant and care provider.

It started in 2017-12-01 with completion listed for 2024-09-30.

It ran at 3 sites in Albania (1), Bulgaria (1) and Italy (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: pregnancy after embryo transfer (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 300 people.

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

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