NCT04166500

Brief Summary

Background: Intrauterine adhesions are a difficult clinical problem for reproductive infertility. The most common cause is uterine cavity surgery and post-abortion (including abortion and spontaneous abortion). After the abortion, the uterine cavity adhesion, when is the key point, the literature is not much ink, early literature has mentioned that after the abortion, the uterus scraping action is scraped in four days and the uterine adhesion will be smaller than one to four weeks. Much more, it seems that the sooner the uterine adhesion factor is excluded, the more it can reduce uterine adhesion, but the uterine curettage itself is a risk factor for uterine adhesion. This early practice, the current clinical application, is not used, Instead, it is a hysteroscopy. Our past clinical observations, as soon as possible after the abortion, outpatient hysteroscopy, can find the tissue factors that may cause adhesion in the uterine cavity as soon as possible, and immediately remove it with an outpatient hysteroscope. Objective: To verify the early outpatient hysteroscopy and reduce the occurrence of intrauterine adhesion after abortion. Expected benefits to patients: Abortion is likely to cause intrauterine adhesions, which may further cause the incidence of reproductive infertility, should be involved before the formation of permanent injury, reduce the adhesion of the uterine cavity. Outpatient hysteroscopy is a simple and easy-to-use examination procedure that is painless and does not require anesthesia. Although it is invasive but has few complications, it is expected to reduce the occurrence of intrauterine adhesion after abortion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

November 10, 2019

Last Update Submit

July 21, 2022

Conditions

HysteroscopyIntrauterine Adhesion

Keywords

Induced abortionUterine adhesionsReproductive infertilityHysteroscopy

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of intrauterine adhesions

    assess with hysteroscopy

    6 months later after induced abortion

Secondary Outcomes (7)

  • The American Fertility Society (AFS) intrauterine adhesion (IUA) score

    6 months later after induced abortion

  • Menstrual cycle condition: Menstrual amount

    6 months later after induced abortion

  • Menstrual cycle condition: Menstrual duration

    6 months later after induced abortion

  • Menstrual cycle condition: Menstrual symptoms

    6 months later after induced abortion

  • Sonography findings:endometrial thickness

    6 months later after induced abortion

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Procedure: Hysteroscopy

Control

NO INTERVENTION

Interventions

HysteroscopyPROCEDURE

outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).

Intervention

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female age 20 to 45 years-old
  • undergo induced abortion
  • desire future fertility
  • agree with the trial and sign the consent form

You may not qualify if:

  • previous intrauterine surgery
  • previous intrauterine adhesion
  • previous having over(and/or equal to) 3 times of induced abortion
  • infection condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 123, Taiwan

Location

Related Publications (1)

  • Tsai NC, Hsiao YY, Su YT, Lin YJ, Kung FT, Chen PH, Lan KC. The efficacy of early office hysteroscopy in preventing intrauterine adhesions after abortion: a randomized controlled trial. BMC Womens Health. 2024 Jul 13;24(1):400. doi: 10.1186/s12905-024-03247-0.

    PMID: 39003483DERIVED

MeSH Terms

Conditions

Gynatresia

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 18, 2019

Study Start

November 1, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations

TW(1)