NCT03421639

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_4

Geographic Reach
3 countries

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

6.8 years

First QC Date

January 30, 2018

Last Update Submit

March 5, 2024

Conditions

Uterine AdenomyosisRecurrent Implantation FailureMenstrual Pain

Keywords

Implantation failureAdenomyosisincreased uterine sizeIVFegg donation cycle

Outcome Measures

Primary Outcomes (1)

  • pregnancy after embryo transfer

    after treatment patients undergo embryo transfer of a cryopreservad blastocyst

    12 months

Secondary Outcomes (1)

  • uterine volume reduction

    12 months

Study Arms (2)

GnRH analog alone

ACTIVE COMPARATOR

control group treated with GnRH analog alone

Drug: GnRH analog (11.25mg Leuprolide acetate)

Aromatase inhibitor plus GnRH analog

EXPERIMENTAL

experimental group treated with aromatase inhibitor plus GnRH analog

Drug: Aromatase inhibitor and GnRH analogDrug: Aromatase and GnRH analog (11.25mg Leuprolide acetate)

Interventions

GnRH analog (11.25mg Leuprolide acetate)DRUG

11.25 Leuprolide acetate only one administration

Also known as: Control group
GnRH analog alone
Aromatase inhibitor and GnRH analogDRUG

1mg/day of Anastrazole for 3 months

Also known as: experimental group
Aromatase inhibitor plus GnRH analog
Aromatase and GnRH analog (11.25mg Leuprolide acetate)DRUG

Leuprolide acetate 11.25mg only one

Also known as: experimental group
Aromatase inhibitor plus GnRH analog

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • presence of systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Spitali Amerikan

Tirana, Albania

Location

Nadezda Women's Health Hospital

Sofia, Bulgaria

Location

Cerm-Hungaria

Rome, 00153, Italy

Location

MeSH Terms

Conditions

AdenomyosisDysmenorrhea

Interventions

Gonadotropin-Releasing HormoneLeuprolideControl GroupsAromatase InhibitorsAromatase

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsSteroid Synthesis InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEstrogen AntagonistsHormone AntagonistsPhysiological Effects of DrugsCytochrome P450 Family 19Cytochrome P-450 Enzyme SystemCytochromesEnzymes and CoenzymesSteroid HydroxylasesMixed Function OxygenasesOxygenasesOxidoreductasesEnzymesHemeproteins

Study Officials

  • MARCO SBRACIA, MD

    CERM-HUNGARIA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Patients will take similar kind medications by an indipendent person
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial in two arms study (150 each one)
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 5, 2018

Study Start

December 1, 2017

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

AL(1)BU(1)IT(1)