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Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

Primary Purpose

Uterine Adenomyosis, Recurrent Implantation Failure, Menstrual Pain

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
GnRH analog (3,75mg Leuprolide)
Aromatase inhibitor plus GnRH analog (3,75mg Leuprolide)
Sponsored by
Centre for Endocrinology and Reproductive Medicine, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Adenomyosis focused on measuring Implantation failure, Adenomyosis, increased uterine size, IVF, egg donation cycle

Eligibility Criteria

30 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of systemic diseases

Sites / Locations

  • Spitali AmerikanRecruiting
  • Nadezda Women's Health HospitalRecruiting
  • Cerm-HungariaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GnRH analog alone

Aromatase inhibitor plus GnRH analog

Arm Description

control group treated with GnRH analog alone

experimental group treated with aromatase inhibitor plus GnRH analog

Outcomes

Primary Outcome Measures

pregnancy after embryo transfer
after treatment patients undergo embryo transfer of a cryopreservad blastocyst

Secondary Outcome Measures

uterine volume reduction
differences in uterine volume pre and post treatment evaluated by ultrasound

Full Information

First Posted
January 30, 2018
Last Updated
July 21, 2022
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03421639
Brief Title
Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis
Official Title
A Controlled Trial on Adenomyosis Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus GnRH Analog Alone
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
September 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Adenomyosis, Recurrent Implantation Failure, Menstrual Pain
Keywords
Implantation failure, Adenomyosis, increased uterine size, IVF, egg donation cycle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial in two arms study (150 each one)
Masking
ParticipantCare Provider
Masking Description
Patients will take similar kind medications by an indipendent person
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRH analog alone
Arm Type
Active Comparator
Arm Description
control group treated with GnRH analog alone
Arm Title
Aromatase inhibitor plus GnRH analog
Arm Type
Experimental
Arm Description
experimental group treated with aromatase inhibitor plus GnRH analog
Intervention Type
Drug
Intervention Name(s)
GnRH analog (3,75mg Leuprolide)
Other Intervention Name(s)
Control group
Intervention Description
3,75 Leuprolide monthly for 3 months
Intervention Type
Drug
Intervention Name(s)
Aromatase inhibitor plus GnRH analog (3,75mg Leuprolide)
Other Intervention Name(s)
experimental group
Intervention Description
1mg/day of Anastrazole plus Leuprolide 3.75mg/monthly for 3 months
Primary Outcome Measure Information:
Title
pregnancy after embryo transfer
Description
after treatment patients undergo embryo transfer of a cryopreservad blastocyst
Time Frame
12 months
Secondary Outcome Measure Information:
Title
uterine volume reduction
Description
differences in uterine volume pre and post treatment evaluated by ultrasound
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women with healty conditions Adenomyosis increased uterine dimensions recurrent implantation failure Exclusion Criteria: presence of systemic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARCO SBRACIA, MD
Phone
+393479037433
Email
marcandrea@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
FABIO SCARPELLINI, MD
Phone
+393278779064
Email
ananchekaityche@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCO SBRACIA, MD
Organizational Affiliation
CERM-HUNGARIA
Official's Role
Study Chair
Facility Information:
Facility Name
Spitali Amerikan
City
Tirana
Country
Albania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avenir Balili, MD
Facility Name
Nadezda Women's Health Hospital
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgi Stamenov, MD
Email
georgistamenov@abv.bg
Facility Name
Cerm-Hungaria
City
Rome
ZIP/Postal Code
00153
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FABIO SCARPELLINI, MD
Phone
+39-3278779064
Email
ananchekaityche@hotmail.com
First Name & Middle Initial & Last Name & Degree
MARCO SBRACIA, MD
Phone
+39-3479037433
Email
marcandrea@hotmail.com
First Name & Middle Initial & Last Name & Degree
FABIO SCARPELLINI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

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