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Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

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ClinicalTrials.gov Identifier: NCT03421639
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uterine Adenomyosis Recurrent Implantation Failure Menstrual Pain Drug: GnRH analog (3,75mg Leuprolide) Drug: Aromatase inhibitor plus GnRH analog (3,75mg Leuprolide) Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial in two arms study (150 each one)
Masking: Double (Participant, Care Provider)
Masking Description: Patients will take similar kind medications by an indipendent person
Primary Purpose: Treatment
Official Title: A Controlled Trial on Adenomyosis Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus GnRH Analog Alone
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : April 28, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: GnRH analog alone
control group treated with GnRH analog alone
 Drug: GnRH analog (3,75mg Leuprolide)
3,75 Leuprolide monthly for 3 months
Other Name: Control group
Experimental: Aromatase inhibitor plus GnRH analog
experimental group treated with aromatase inhibitor plus GnRH analog
 Drug: Aromatase inhibitor plus GnRH analog (3,75mg Leuprolide)
1mg/day of Anastrazole plus Leuprolide 3.75mg/monthly for 3 months
Other Name: experimental group


Outcome Measures
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Primary Outcome Measures :
  1. pregnancy after embryo transfer [ Time Frame: 12 months ]
    after treatment patients undergo embryo transfer of a cryopreservad blastocyst


Secondary Outcome Measures :
  1. uterine volume reduction [ Time Frame: 12 months ]
    differences in uterine volume pre and post treatment evaluated by ultrasound


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of systemic diseases
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421639


Contacts
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Contact: MARCO SBRACIA, MD +393479037433 marcandrea@hotmail.com
Contact: FABIO SCARPELLINI, MD +393278779064 ananchekaityche@hotmail.com

Locations
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Albania
Spitali Amerikan Recruiting
Tirana, Albania
Contact: Avenir Balili, MD         
Bulgaria
Nadezda Women's Health Hospital Recruiting
Sofia, Bulgaria
Contact: Georgi Stamenov, MD         
Contact       georgistamenov@abv.bg   
Italy
Cerm-Hungaria Recruiting
Rome, Italy, 00153
Contact: FABIO SCARPELLINI, MD    +39-3278779064    ananchekaityche@hotmail.com   
Contact: MARCO SBRACIA, MD    +39-3479037433    marcandrea@hotmail.com   
Principal Investigator: FABIO SCARPELLINI, MD         
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Investigators
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Study Chair: MARCO SBRACIA, MD CERM-HUNGARIA
More Information
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Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier: NCT03421639    
Other Study ID Numbers: CR-01-18
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre for Endocrinology and Reproductive Medicine, Italy:
Implantation failure
Adenomyosis
increased uterine size
IVF
egg donation cycle
Additional relevant MeSH terms:
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Adenomyosis
Dysmenorrhea
Uterine Diseases
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Leuprolide
Prolactin Release-Inhibiting Factors
Aromatase Inhibitors
Fertility Agents, Female
 Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists