NCT04930913

Brief Summary

In this prospective, multicenter, large-scale study，the investigators wish to examine the accuracy of several three-dimensional ultrasound anatomical and vascular parameters in diagnosing IUA when compared to the gold standard of hysteroscopy，and to assess the value of 3D US applying in prognosis of intrauterine adhesions.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 11, 2021

Last Update Submit

June 16, 2021

Conditions

Intrauterine Adhesion

Outcome Measures

Primary Outcomes (1)

  • Endometrial volume

    Endometrial volume will be measured in in luteal phase by 3D US

    1 year

Interventions

Three-dimensional UltrasoundDIAGNOSTIC_TEST

women suspected of having adhesions will perform 3D US

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

600 patients from three Tertiary hospitals suspected of having IUA will be prospectively recruited

You may qualify if:

  • women aged 20-40
  • oligomenorrhea or amenorrhea
  • BMI 18-30
  • regular menstruation
  • written consent obtained

You may not qualify if:

  • Hypothalamic amenorrhea, pituitary amenorrhea and ovarian amenorrhea
  • Patients with uterine fibroids, adenomyosis, uterine malformation and endometrial polyps
  • Patients with uterine artery embolization
  • History of endometrial hyperplasia
  • Irregular menstruation
  • Patients with severe complications
  • Patients with hypoovarian function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Xing Hospital, Capital Medical University

Beijing, 100038, China

RECRUITING

Related Publications (6)

  • Kim MJ, Lee Y, Lee C, Chun S, Kim A, Kim HY, Lee JY. Accuracy of three dimensional ultrasound and treatment outcomes of intrauterine adhesion in infertile women. Taiwan J Obstet Gynecol. 2015 Dec;54(6):737-41. doi: 10.1016/j.tjog.2015.10.011.

    PMID: 26700995BACKGROUND

  • Amin TN, Saridogan E, Jurkovic D. Ultrasound and intrauterine adhesions: a novel structured approach to diagnosis and management. Ultrasound Obstet Gynecol. 2015 Aug;46(2):131-9. doi: 10.1002/uog.14927. Epub 2015 Jul 20. No abstract available.

    PMID: 26094824BACKGROUND

  • Carrascosa P, Capunay C, Vallejos J, Carpio J, Baronio M, Papier S. Two-dimensional and three-dimensional imaging of uterus and fallopian tubes in female infertility. Fertil Steril. 2016 Jun;105(6):1403-1420.e7. doi: 10.1016/j.fertnstert.2016.04.016. Epub 2016 Apr 29.

    PMID: 27140290BACKGROUND

  • AAGL Elevating Gynecologic Surgery. AAGL practice report: practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy (ESGE). Gynecol Surg. 2017;14(1):6. doi: 10.1186/s10397-017-1007-3. Epub 2017 May 1. No abstract available.

    PMID: 28603474BACKGROUND

  • Salazar CA, Isaacson K, Morris S. A comprehensive review of Asherman's syndrome: causes, symptoms and treatment options. Curr Opin Obstet Gynecol. 2017 Aug;29(4):249-256. doi: 10.1097/GCO.0000000000000378.

    PMID: 28582327BACKGROUND

  • Dreisler E, Kjer JJ. Asherman's syndrome: current perspectives on diagnosis and management. Int J Womens Health. 2019 Mar 20;11:191-198. doi: 10.2147/IJWH.S165474. eCollection 2019.

    PMID: 30936754BACKGROUND

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Li Tinchiu

    Fuxing Hospital,Capital Medical University

    STUDY CHAIR

Central Study Contacts

Huang xiaowu

CONTACT

+8613810828816hxiaowu_fxyy@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 18, 2021

Study Start

July 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)