HysteroscopyNCT04166500
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion
A study testing Hysteroscopy in people with Hysteroscopy and Intrauterine Adhesion, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopy, Intrauterine Adhesion
- What is being tested?
- Hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2019to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female age 20 to 45 years-old
- undergo induced abortion
- desire future fertility
- agree with the trial and sign the consent form
Who cannot join
- previous intrauterine surgery
- previous intrauterine adhesion
- previous having over(and/or equal to) 3 times of induced abortion
- infection condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion: a Randomized Controlled Trial
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.
- Conditions
- Hysteroscopy, Intrauterine Adhesion
- Being tested
- Hysteroscopy
- Keywords
- Induced abortion, Uterine adhesions, Reproductive infertility, Hysteroscopy
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyProcedure or surgery
outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Procedure: Hysteroscopy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of intrauterine adhesions
assess with hysteroscopy
Measured: 6 months later after induced abortion
Secondary outcomes (7)
The American Fertility Society (AFS) intrauterine adhesion (IUA) score
Assess by hysteroscopy and measure with IUA score. Score scaling from 1 to 12 with the higher scores mean a worse outcome. Stage I (mild, 1-4), stage II (moderate, 5-8); stage III (severe, 9-12).
Measured: 6 months later after induced abortion
Menstrual cycle condition: Menstrual amount
Normal/Hypo/Hyper by Pictorial blood loss assessment charts (PBACs): self-reported by patients and questionnaire.
Normal amount: 10 to 100 points. Hypermenorrhea: over 100 points. Hypomenorrhea: less than 10 points.
Measured: 6 months later after induced abortion
Menstrual cycle condition: Menstrual duration
days: by questionnaire
Measured: 6 months later after induced abortion
Menstrual cycle condition: Menstrual symptoms
dysmenorrhea/no dysmenorrhea: by questionnaire
Measured: 6 months later after induced abortion
Sonography findings:endometrial thickness
centimeters
Measured: 6 months later after induced abortion
Sonography findings: morphology
Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)
Measured: 6 months later after induced abortion
Fertility outcome
Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth
Measured: 2 years later after induced abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Nov 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166500
- Sponsor's protocol ID
- CMRPG8J1131
- Status last verified
- Jul 2022
- First submitted
- 10 Nov 2019
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39003483
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04166500
- Acronym / sponsor ID
- CMRPG8J1131
- Conditions
- Hysteroscopy, Intrauterine Adhesion
- Keywords
- Induced abortion, Uterine adhesions, Reproductive infertility, Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Hysteroscopy |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female age 20 to 45 years-old
- undergo induced abortion
- desire future fertility
- agree with the trial and sign the consent form
Key exclusion criteria (4 listed)
- previous intrauterine surgery
- previous intrauterine adhesion
- previous having over(and/or equal to) 3 times of induced abortion
- infection condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopyoutpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days). | Procedure or surgery | Intervention |
Primary outcome
Incidence rate of intrauterine adhesions
Time frame: 6 months later after induced abortion
assess with hysteroscopy
7 secondary outcomes
The American Fertility Society (AFS) intrauterine adhesion (IUA) score
Time frame: 6 months later after induced abortion
Menstrual cycle condition: Menstrual amount
Time frame: 6 months later after induced abortion
Menstrual cycle condition: Menstrual duration
Time frame: 6 months later after induced abortion
Menstrual cycle condition: Menstrual symptoms
Time frame: 6 months later after induced abortion
Sonography findings:endometrial thickness
Time frame: 6 months later after induced abortion
Sonography findings: morphology
Time frame: 6 months later after induced abortion
Fertility outcome
Time frame: 2 years later after induced abortion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 39003483Tsai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy in people with Hysteroscopy and Intrauterine Adhesion, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of intrauterine adhesions (time frame: 6 months later after induced abortion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04166500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.