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NCT03421639 Clinical Trial

Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

Recurrent Implantation Failure Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03421639
Other study ID # CR-01-18
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date December 1, 2017
Est. completion date September 30, 2024

Study information
Verified date March 2024
Source Centre for Endocrinology and Reproductive Medicine, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria: - women with healty conditions - Adenomyosis - increased uterine dimensions - recurrent implantation failure Exclusion Criteria: - presence of systemic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GnRH analog (11.25mg Leuprolide acetate)
11.25 Leuprolide acetate only one administration
• Aromatase inhibitor and GnRH analog
1mg/day of Anastrazole for 3 months
• Aromatase and GnRH analog (11.25mg Leuprolide acetate)
Leuprolide acetate 11.25mg only one

Locations
Country Name City State
Albania Spitali Amerikan Tirana
Bulgaria Nadezda Women's Health Hospital Sofia
Italy Cerm-Hungaria Rome

Sponsors (1)
Lead Sponsor Collaborator
Centre for Endocrinology and Reproductive Medicine, Italy

Countries where clinical trial is conducted

Albania,  Bulgaria,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary pregnancy after embryo transfer after treatment patients undergo embryo transfer of a cryopreservad blastocyst 12 months
Secondary uterine volume reduction differences in uterine volume pre and post treatment evaluated by ultrasound 12 months
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