Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

Phase 4

Active, not recruiting

• Conditions: Menstrual Pain; Recurrent Implantation Failure; Uterine Adenomyosis
• Interventions: Drug: GnRH analog (11.25mg Leuprolide acetate); Drug: Aromatase inhibitor and GnRH analog; Drug: Aromatase and GnRH analog (11.25mg Leuprolide acetate)

• Registration Number: NCT03421639
• Lead Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• presence of systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH analog alone	GnRH analog (11.25mg Leuprolide acetate)	control group treated with GnRH analog alone
Aromatase inhibitor plus GnRH analog	Aromatase and GnRH analog (11.25mg Leuprolide acetate)	experimental group treated with aromatase inhibitor plus GnRH analog
Aromatase inhibitor plus GnRH analog	Aromatase inhibitor and GnRH analog	experimental group treated with aromatase inhibitor plus GnRH analog

Primary Outcome Measures

Name	Time	Method
pregnancy after embryo transfer	12 months	after treatment patients undergo embryo transfer of a cryopreservad blastocyst

Secondary Outcome Measures

Name	Time	Method
uterine volume reduction	12 months	differences in uterine volume pre and post treatment evaluated by ultrasound

Trial Locations

Locations (3)

Spitali Amerikan; 🇦🇱 Tirana, Albania

Cerm-Hungaria; 🇮🇹 Rome, Italy

Nadezda Women's Health Hospital; 🇧🇬 Sofia, Bulgaria