Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Uterine Adenomyosis; Recurrent Implantation Failure; Menstrual Pain
• Intervention / Treatment: Drug: GnRH analog (11.25mg Leuprolide acetate); Drug: Aromatase inhibitor and GnRH analog; Drug: Aromatase and GnRH analog (11.25mg Leuprolide acetate)

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: MARCO SBRACIA, MD; Phone Number: +393479037433; Email: marcandrea@hotmail.com
• Study Contact Backup: Name: FABIO SCARPELLINI, MD; Phone Number: +393278779064; Email: ananchekaityche@hotmail.com

Study Locations

• Albania
  • Tirana, Albania
    • Spitali Amerikan
• Bulgaria
  • Sofia, Bulgaria
    • Nadezda Women's Health Hospital
• Italy
  • Rome, Italy, 00153
    • Cerm-Hungaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• presence of systemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GnRH analog alone; control group treated with GnRH analog alone	Drug: GnRH analog (11.25mg Leuprolide acetate); 11.25 Leuprolide acetate only one administration; Other Names: Control group
Experimental: Aromatase inhibitor plus GnRH analog; experimental group treated with aromatase inhibitor plus GnRH analog	Drug: Aromatase inhibitor and GnRH analog; 1mg/day of Anastrazole for 3 months; Other Names: experimental group; Drug: Aromatase and GnRH analog (11.25mg Leuprolide acetate); Leuprolide acetate 11.25mg only one; Other Names: experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy after embryo transfer	after treatment patients undergo embryo transfer of a cryopreservad blastocyst	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uterine volume reduction	differences in uterine volume pre and post treatment evaluated by ultrasound	12 months

Collaborators and Investigators

• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy
• Investigators: Study Chair: MARCO SBRACIA, MD, Cerm-Hungaria

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: IVF; Adenomyosis; Implantation failure; increased uterine size; egg donation cycle
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Uterine Diseases; Menstruation Disturbances; Pelvic Pain; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Dysmenorrhea; Adenomyosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide; Prolactin Release-Inhibiting Factors; Aromatase Inhibitors
• Other Study ID Numbers: CR-01-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No