Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

A Controlled Trial on Adenomyosis Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus GnRH Analog Alone

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03421639

Enrollment

300

Registered

2018-02-05

Start date

2017-12-01

Completion date

2024-09-30

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstrual Pain, Recurrent Implantation Failure, Uterine Adenomyosis

Keywords

Implantation failure, Adenomyosis, increased uterine size, IVF, egg donation cycle

Brief summary

With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.

Detailed description

Recently it has been shown that adenomyosis negatively affects the pregnancy rate in IVF cycles. 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. For these reasons the investigators set this controlled trial between GnRH analog plus Aromatase Inhibitor (3.75 mg monthly of Leuprolide plus 1.0mg day of Anastrazole for 3 months) versus an active comparator as GnRH analog alone (3.75 mg monthly of Leuprolide for 3 months) after the treatment patients will undergo embryo transfer of a cryopreserved blastocyst in a previous IVF cycle, and will be followed up for uterine dimension reduction and pain symptom reduction.

Interventions

DRUGGnRH analog (11.25mg Leuprolide acetate)

11.25 Leuprolide acetate only one administration

DRUGAromatase inhibitor and GnRH analog

1mg/day of Anastrazole for 3 months

DRUGAromatase and GnRH analog (11.25mg Leuprolide acetate)

Leuprolide acetate 11.25mg only one

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Masking description

Patients will take similar kind medications by an indipendent person

Intervention model description

Randomized controlled trial in two arms study (150 each one)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* women with healty conditions * Adenomyosis * increased uterine dimensions * recurrent implantation failure

Exclusion criteria

* presence of systemic diseases

Design outcomes

Primary

Measure	Time frame	Description
pregnancy after embryo transfer	12 months	after treatment patients undergo embryo transfer of a cryopreservad blastocyst

Secondary

Measure	Time frame	Description
uterine volume reduction	12 months	differences in uterine volume pre and post treatment evaluated by ultrasound

Countries

Albania, Bulgaria, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026