Intrauterine AdhesionsNCT02744807
Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions
An observational study of Intrauterine Adhesions and Chronic Endometritis, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without CE. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesions, Chronic Endometritis
- What is being tested?
- Chronic endometritis
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Feb 2016
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: A total of 125 patients who received hysteroscopy in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Sun Yat-sen University and were diagnosed with moderate to severe Intrauterine adhesion according to the criteria of American Fertility Society (AFS) were recruited into present study.
Who may be able to join
- Pre-operative adhesion score was ≥5
- The prior menstrual cycle was regular, and the sex hormone was normal
- with informed consent
- absence of other uterine abnormality at transvaginal ultrasound
- There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery.
Who cannot join
- Pre-operative adhesion score was <5
- Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
- other uterine abnormality at transvaginal ultrasound
- without informed consent
- Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma
- refuse Endometrial biopsy
- Vaginal discharge abnormal, or Suspected vaginitis or pelvic inflammatory disease, or using antibiotics.
About this study
Official title: Prevalence of Chronic Endometritis in Severe Intrauterine Adhesions and Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine
This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without CE.
Read the detailed description
Chronic endometritis (CE) is a persistent in endometrium that is characterized by the presence of plasma cells. Recently, there has been increasing interest in the role of CE in recurrent pregnancy loss (RPL). One of the most common uterine abnormalities for RPL is Intrauterine adhesion (IUA).Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health.It is well established that the formation of IUA likely involves hypoxia, reduced neovascularization, and altered expression of adhesion-associated cytokines, but the exact mechanisms are not well understood. Although excessive curettage is considered the primary cause, intrauterine adhesion is known to be associated with diverse non-traumatic factors, such as postabortal sepsis, puerperal sepsis and infections. It is therefore possible to hypothesize that Intrauterine adhesion may be related to chronic endometritis. To the best of researchers knowledge,there have been no reports investigating this relationship. The aim of this study was to clarify the hypothesis by evaluating the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without chronic endometritis (CE).
- Conditions
- Intrauterine Adhesions, Chronic Endometritis
- Being tested
- Chronic endometritis
- Keywords
- intrauterine adhesions, Chronic endometritis, infections, Hysteroscopy
- Medical subject headings
- Gynatresia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic endometritisOther
with or without Chronic endometritis
| Study group | Role | What they receive |
|---|---|---|
| non-Chronic endometritis | patients with intrauterine adhesion only | |
| Chronic endometritis | patients with intrauterine adhesion as well as Chronic endometritis Receives: Other: Chronic endometritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With recurrence of adhesion in women with and without Chronic endometritis
Second-look hysteroscopy was carried out in the early proliferative phase, 1 to 3 months after the initial operation.After assessment of the extent and severity of any reformed adhesions, hysteroscopic adhesiolysis was also carried out at the time of the second-look procedure, if adhesions had recurred.
Measured: 1 year
Secondary outcomes (3)
Reduction of American Fertility Society adhesion score at Second-look hysteroscopy between women with and without Chronic endometritis
The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version) [7]. A score of 1-4 was considered to represent mild adhesions, a score of 5-8 was considered to represent moderate adhesions and a score of 9-12 represented severe adhesions.
Measured: 1 year
Number of patients diagnosed with Chronic endometritis at hysteroscopy
Chronic endometritis signs at hysteroscopy included [1] pedunculated and vascularized micro-polyps (<1 mm), most frequently found near the endocervical area (2); and [2] the presence of areas of hyperemic endometrium flushed with a white central point, localized or scattered throughout the cavity, referred to as "strawberry aspect".
Measured: 1 year
Number of patients with Chronic endometritis confirmed by histology
Endometrial samples were fixed in neutral formalin and later embedded in paraffin for histological analysis. Five-micrometer sections were stained with hematoxilin-eosin. Histological diagnosis of Chronic endometritis: Attention was paid to the following features: superficial stromal edema, increased stromal density, pleomorphic stromal inflammatory infiltrate dominated by lymphocytes and plasma cells.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- chen yu qing, Deputy chief, Principal investigator, The First Affiliated Hospital of SunYetSen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744807
- Sponsor's protocol ID
- 2013B021800237
- Status last verified
- Apr 2016
- First submitted
- 10 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
McQueen DB, Perfetto CO, Hazard FK, Lathi RB. Pregnancy outcomes in women with chronic endometritis and recurrent pregnancy loss. Fertil Steril. 2015 Oct;104(4):927-931. doi: 10.1016/j.fertnstert.2015.06.044. Epub 2015 Jul 21.
PubMed 26207958Liu L, Yang H, Guo Y, Yang G, Chen Y. The impact of chronic endometritis on endometrial fibrosis and reproductive prognosis in patients with moderate and severe intrauterine adhesions: a prospective cohort study. Fertil Steril. 2019 May;111(5):1002-1010.e2. doi: 10.1016/j.fertnstert.2019.01.006. Epub 2019 Mar 25.
PubMed 30922643Chen Y, Liu L, Luo Y, Chen M, Huan Y, Fang R. Prevalence and Impact of Chronic Endometritis in Patients With Intrauterine Adhesions: A Prospective Cohort Study. J Minim Invasive Gynecol. 2017 Jan 1;24(1):74-79. doi: 10.1016/j.jmig.2016.09.022. Epub 2016 Oct 20.
PubMed 27773811
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Endometritis in Severe Intrauterine Adhesions and Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine
- ClinicalTrials.gov ID
- NCT02744807
- Acronym / sponsor ID
- 2013B021800237
- Conditions
- Intrauterine Adhesions, Chronic Endometritis
- Keywords
- intrauterine adhesions, Chronic endometritis, infections, Hysteroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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.
This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without CE.
Detailed description
Chronic endometritis (CE) is a persistent in endometrium that is characterized by the presence of plasma cells. Recently, there has been increasing interest in the role of CE in recurrent pregnancy loss (RPL). One of the most common uterine abnormalities for RPL is Intrauterine adhesion (IUA).Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health.It is well established that the formation of IUA likely involves hypoxia, reduced neovascularization, and altered expression of adhesion-associated cytokines, but the exact mechanisms are not well understood. Although excessive curettage is considered the primary cause, intrauterine adhesion is known to be associated with diverse non-traumatic factors, such as postabortal sepsis, puerperal sepsis and infections. It is therefore possible to hypothesize that Intrauterine adhesion may be related to chronic endometritis. To the best of researchers knowledge,there have been no reports investigating this relationship. The aim of this study was to clarify the hypothesis by evaluating the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without chronic endometritis (CE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-Chronic endometritis | – | –patients with intrauterine adhesion only |
| Chronic endometritis | – | Other: Chronic endometritispatients with intrauterine adhesion as well as Chronic endometritis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of 125 patients who received hysteroscopy in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Sun Yat-sen University and were diagnosed with moderate to severe Intrauterine adhesion according to the criteria of American Fertility Society (AFS) were recruited into present study.
Key inclusion criteria (5 listed)
- Pre-operative adhesion score was ≥5
- The prior menstrual cycle was regular, and the sex hormone was normal
- with informed consent
- absence of other uterine abnormality at transvaginal ultrasound
- There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery.
Key exclusion criteria (7 listed)
- Pre-operative adhesion score was <5
- Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
- other uterine abnormality at transvaginal ultrasound
- without informed consent
- Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma
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 |
|---|---|---|
| Chronic endometritiswith or without Chronic endometritis | Other | Chronic endometritis |
Primary outcome
Number of Participants With recurrence of adhesion in women with and without Chronic endometritis
Time frame: 1 year
Second-look hysteroscopy was carried out in the early proliferative phase, 1 to 3 months after the initial operation.After assessment of the extent and severity of any reformed adhesions, hysteroscopic adhesiolysis was also carried out at the time of the second-look procedure, if adhesions had recurred.
3 secondary outcomes
Reduction of American Fertility Society adhesion score at Second-look hysteroscopy between women with and without Chronic endometritis
Time frame: 1 year
Number of patients diagnosed with Chronic endometritis at hysteroscopy
Time frame: 1 year
Number of patients with Chronic endometritis confirmed by histology
Time frame: 1 year
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 20 Apr 2016.
- Background: PubMed 26207958McQueen DB, Perfetto CO, Hazard FK, Lathi RB. Pregnancy outcomes in women with chronic endometritis and recurrent pregnancy loss. Fertil Steril. 2015 Oct;104(4):927-931. doi: 10.1016/j.fertnstert.2015.06.044. Epub 2015 Jul 21.
- Derived from this study: PubMed 30922643Liu L, Yang H, Guo Y, Yang G, Chen Y. The impact of chronic endometritis on endometrial fibrosis and reproductive prognosis in patients with moderate and severe intrauterine adhesions: a prospective cohort study. Fertil Steril. 2019 May;111(5):1002-1010.e2. doi: 10.1016/j.fertnstert.2019.01.006. Epub 2019 Mar 25.
- Derived from this study: PubMed 27773811Chen Y, Liu L, Luo Y, Chen M, Huan Y, Fang R. Prevalence and Impact of Chronic Endometritis in Patients With Intrauterine Adhesions: A Prospective Cohort Study. J Minim Invasive Gynecol. 2017 Jan 1;24(1):74-79. doi: 10.1016/j.jmig.2016.09.022. Epub 2016 Oct 20.
- Individual participant dataSharing planned: Yes
Related trials for Intrauterine Adhesions
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Recruiting
Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Intrauterine Adhesion
Recruiting
To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial
Intrauterine Adhesion, Intrauterine Adhesions
Not yet recruiting
Clinical Study of i-PRF Intrauterine Perfusion for Endometrial Regeneration and Repair in Moderate to Severe Intrauterine Adhesions
Intrauterine Adhesions
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.
chen yu qing, Deputy chief principal investigator
The First Affiliated Hospital of SunYetSen University
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Adhesions and Chronic Endometritis, run by First Affiliated Hospital, Sun Yat-Sen University.
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 5 inclusion and 7 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of Participants With recurrence of adhesion in women with and without Chronic endometritis (time frame: 1 year). 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 NCT02744807, which also lists 3 linked publications.
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 20 Apr 2016.