NCT06250569

Brief Summary

  1. 1.To estimate the prevalence of adenomyosis in fertile women aged 18-30 years using the revised MUSA ultrasound criteria.
  2. 2.To evaluate clinical risk factors that are associated with adenomyosis diagnosis in this population

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

January 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

January 26, 2024

Last Update Submit

February 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • adenomyosis in fertile women

    Estimation of the prevalence of adenomyosis diagnosed using revised MUSA criteria among fertile women aged 18-30 years.

    1.5 year

Study Arms (2)

first group

women with with adenomyosis

second group

women without adenomyosis

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study will include women with regular menstrual cycle attending outpatient clinic for contraception counseling( age 18 -30 years old ; written consent will be obtained )

You may qualify if:

  • women with regular menstrual cycle attending outpatient clinic for contraception counseling
  • age 18 -30 years old

You may not qualify if:

  • Women on hormonal contraception
  • Infertile women
  • Associated pathologies like endometriosis, uterine fibroids. and ovarian cysts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, 71515, Egypt

Location

Related Publications (4)

  • Marion LL, Meeks GR. Ectopic pregnancy: History, incidence, epidemiology, and risk factors. Clin Obstet Gynecol. 2012 Jun;55(2):376-86. doi: 10.1097/GRF.0b013e3182516d7b.

    PMID: 22510618BACKGROUND
  • Practice Committee of American Society for Reproductive Medicine. Medical treatment of ectopic pregnancy. Fertil Steril. 2008 Nov;90(5 Suppl):S206-12. doi: 10.1016/j.fertnstert.2008.08.049.

    PMID: 19007632BACKGROUND
  • Karol D, Williamson M, Pereira N. Successful Expectant Management of a Tubal Ectopic Pregnancy. J Minim Invasive Gynecol. 2024 Feb;31(2):92-94. doi: 10.1016/j.jmig.2023.11.011. Epub 2023 Nov 30. No abstract available.

    PMID: 38042476BACKGROUND
  • Harmsen MJ, Van den Bosch T, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Hehenkamp WJK, Groenman F, De Bruyn C, Rasmussen C, Lazzeri L, Jokubkiene L, Jurkovic D, Naftalin J, Tellum T, Bourne T, Timmerman D, Huirne JAF. Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure. Ultrasound Obstet Gynecol. 2022 Jul;60(1):118-131. doi: 10.1002/uog.24786.

    PMID: 34587658BACKGROUND

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • safwat abdelrady, Prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Aya Nour elzanaty, MBBch

CONTACT

Essam Rashad, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal invistigator

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 9, 2024

Study Start

February 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations