Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

Centre for Endocrinology and Reproductive Medicine, Italy

Status and phase: Active, not recruiting; Phase 4

Conditions: Menstrual Pain; Recurrent Implantation Failure; Uterine Adenomyosis

Treatments: Drug: Aromatase and GnRH analog (11.25mg Leuprolide acetate); Drug: Aromatase inhibitor and GnRH analog; Drug: GnRH analog (11.25mg Leuprolide acetate)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03421639

CR-01-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• presence of systemic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

GnRH analog alone

Active Comparator group

Description:

control group treated with GnRH analog alone

Treatment:

Drug: GnRH analog (11.25mg Leuprolide acetate)

Aromatase inhibitor plus GnRH analog

Experimental group

Description:

experimental group treated with aromatase inhibitor plus GnRH analog

Treatment:

Drug: Aromatase inhibitor and GnRH analog

Drug: Aromatase and GnRH analog (11.25mg Leuprolide acetate)