NCT03421639

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: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy · Network
• Sex: Female
• Age: 30 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Uterine Adenomyosis
• Recurrent Implantation Failure
• Menstrual Pain

Interventions

Type	Name	Description
DRUG	GnRH analog (11.25mg Leuprolide acetate)	11.25 Leuprolide acetate only one administration
DRUG	Aromatase inhibitor and GnRH analog	1mg/day of Anastrazole for 3 months
DRUG	Aromatase and GnRH analog (11.25mg Leuprolide acetate)	Leuprolide acetate 11.25mg only one

Timeline

• Start date: 2017-12-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2018-02-05
• Last updated: 2024-03-06

Locations

3 sites across 3 countries: Albania, Bulgaria, Italy