Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

NCT ID: NCT03421639

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2024-09-30

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.

Conditions

Uterine Adenomyosis; Recurrent Implantation Failure; Menstrual Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GnRH analog alone

control group treated with GnRH analog alone

Group Type: ACTIVE_COMPARATOR

GnRH analog (11.25mg Leuprolide acetate)

Intervention Type: DRUG

11.25 Leuprolide acetate only one administration

Aromatase inhibitor plus GnRH analog

experimental group treated with aromatase inhibitor plus GnRH analog

Group Type: EXPERIMENTAL

Aromatase inhibitor and GnRH analog

Intervention Type: DRUG

1mg/day of Anastrazole for 3 months

Aromatase and GnRH analog (11.25mg Leuprolide acetate)

Intervention Type: DRUG

Leuprolide acetate 11.25mg only one

Interventions

GnRH analog (11.25mg Leuprolide acetate)

11.25 Leuprolide acetate only one administration

Intervention Type: DRUG

Aromatase inhibitor and GnRH analog

1mg/day of Anastrazole for 3 months

Intervention Type: DRUG

Aromatase and GnRH analog (11.25mg Leuprolide acetate)

Leuprolide acetate 11.25mg only one

Intervention Type: DRUG

Other Intervention Names

Control group; experimental group; experimental group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• presence of systemic diseases

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Endocrinology and Reproductive Medicine, Italy

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MARCO SBRACIA, MD

Role: STUDY_CHAIR

CERM-HUNGARIA

Locations

Spitali Amerikan

Tirana, , Albania

Nadezda Women's Health Hospital

Sofia, , Bulgaria

Cerm-Hungaria

Rome, , Italy

Countries

Albania; Bulgaria; Italy

Other Identifiers

CR-01-18

Identifier Type: -

Identifier Source: org_study_id