Risk Factors and Disorders Linked to Uterine Adenomyosis... | NCT06697444

Studies
Risk Factors and Disorders Linked to Uterine Adenomyosis on MRI in Reproductive-Age Women

NCT06697444

Sponsor

Mashhad University of Medical Sciences

Status

Completed

Last Update Posted

Nov 20, 2024Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Adenomyosis
Endometriosis
Leiomyoma (Uterine Fibroids)
Ovarian Cysts

Interventions

Not provided

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Nov 14, 2024

First Submission Date that Met QC Criteria

Nov 17, 2024

First Posted Date

Nov 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2024

Last Update Posted Date

Nov 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational case-control study is to identify risk factors and associated conditions related to adenomyosis in women of reproductive age.

The main questions it aims to answer are:

Is there an association between a history of uterine surgery and the occurrence of adenomyosis? Does a higher prevalence of endometriosis or increased number of pregnancies correlate with adenomyosis? Researchers will compare women with MRI-confirmed adenomyosis to a control group of women who underwent pelvic MRI for other reasons but were not diagnosed with adenomyosis to see if there are significant differences in risk factors such as endometriosis, number of pregnancies, and history of uterine surgery.

Participants will:

Undergo pelvic MRI with and without intravenous contrast Provide information on factors such as age, smoking, number of pregnancies, history of uterine surgery, and coexisting conditions like leiomyoma and ovarian cysts This study aims to inform better management strategies for reducing the incidence of adenomyosis by targeting modifiable risk factors.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of Endometriosis in Participants Diagnosed with MRI-Confirmed Adenomyosis	he presence of endometriosis will be evaluated in participants who have been diagnosed with adenomyosis through pelvic MRI. Diagnosis will be confirmed based on established imaging criteria, including areas of low signal intensity on T2-weighted MRI images. The prevalence will be compared between the case group (women with adenomyosis) and the control group (women without adenomyosis). The outcome will be reported as the percentage of participants in each group diagnosed with endometriosis.	From admission to discharge, up to 1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women of reproductive age (18-50 years).
Patients who underwent pelvic MRI for clinical indications.
MRI-confirmed diagnosis of adenomyosis (for the case group).
Patients without adenomyosis confirmed by MRI (for the control group).
Willingness to participate and provide informed consent.

Exclusion Criteria:

Women outside the reproductive age range (under 18 or over 50 years).
Pregnancy or lactation at the time of MRI.
Previous hysterectomy or other major uterine surgeries.
Presence of malignancies or other serious conditions that could interfere with the study.
Inability to undergo MRI due to contraindications (e.g., metal implants, pacemakers).
Incomplete or missing MRI data.
Non-consent to participate in the study.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Only individuals who self-identify as female were eligible to participate in this study, as it focused on conditions specific to the uterus.

Minimum Age

Not provided

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Case Group: 50 women of reproductive age (18-50 years) who were diagnosed with adenomyosis based on MRI findings.

Control Group: 50 women of reproductive age (18-50 years) who underwent pelvic MRI for various clinical reasons but were not diagnosed with adenomyosis.

Sampling Method

Non-Probability Sample

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jan 1, 2023	Nov 14, 2024	SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D062788	Adenomyosis
D004715	Endometriosis
D007889	Leiomyoma
D010048	Ovarian Cysts

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

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