Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Adenomyosis, Recurrent Implantation Failure, Menstrual Pain

Intervention / Treatment
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* Drug: GnRH analog (3,75mg Leuprolide)
* Drug: Aromatase inhibitor plus GnRH analog (3,75mg Leuprolide)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with healty conditions Adenomyosis increased uterine dimensions recurrent implantation failure Exclusion Criteria: presence of systemic diseases

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial in two arms study (150 each one)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GnRH analog alone<br>control group treated with GnRH analog alone | Drug: GnRH analog (3,75mg Leuprolide)<br>* 3,75 Leuprolide monthly for 3 months<br>* Other names: Control group;|
| Experimental: Aromatase inhibitor plus GnRH analog<br>experimental group treated with aromatase inhibitor plus GnRH analog | Drug: Aromatase inhibitor plus GnRH analog (3,75mg Leuprolide)<br>* 1mg/day of Anastrazole plus Leuprolide 3.75mg/monthly for 3 months<br>* Other names: experimental group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy after embryo transfer | after treatment patients undergo embryo transfer of a cryopreservad blastocyst | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine volume reduction | differences in uterine volume pre and post treatment evaluated by ultrasound | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantation failure, Adenomyosis, increased uterine size, IVF, egg donation cycle