Intrauterine AdhesionsNCT03731689
Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora
A study testing Intrauterine lavage therapy and Intrauterine gel-injection therapy in people with Intrauterine Adhesions, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis. 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
- Intrauterine Adhesions
- What is being tested?
- Intrauterine lavage therapy and Intrauterine gel-injection therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Dec 2021
- 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
- Pre-operative adhesion score was ≥5
- The prior menstrual cycle was regular, and the sex hormone was normal
- Patients had fertility requirement
- Male semen examination showed normal
- There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery
- regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity
- the healthy women recruited had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization.
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
- Patients had no fertility requirement
- Patients(experimental group and control group) had male factor infertility
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou
Guangdong, Guangzhou, Guangdong, 510000
Yaling Guo, Master, 15622327162, 1106561876@qq.com
Yuqing Chen, Chief, 13724067575, fangchenyq@163.com
About this study
This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis.
Read the detailed description
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 intrauterine adhesion 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. Intrauterine adhesion separation surgery is the gold standard for the treatment of uterine adhesion. Although the success rate is as high as 95%, the patients with moderate or severe uterine adhesion have severe damage to the endometrial basement, poor regeneration of endometrial and gland, poor tolerance of endometrial and poor clinical prognosis. Even if all kinds of anti-adhesion measures are used comprehensively, the postoperative recurrence rate of patients with moderate and severe uterine adhesion is high.Therefore this study was conducted to investigate whether intrauterine lavage or intrauterine gel-injection therapy after surgery could reduce the recurrence of intrauterine adhesion, promote the endometrial growth and repair and improve the menstruation and reproductive prognosis for severe intrauterine adhesion, and we hypothesize that intrauterine adhesion may be related to changes in microbial flora in the reproductive tract.
- Conditions
- Intrauterine Adhesions
- Being tested
- Intrauterine lavage therapy, Intrauterine gel-injection therapy
- Keywords
- intrauterine lavage therapy, hysteroscopy, microbiome, uterine endometrial repair, intrauterine gel-injection therapy
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine lavage therapyDrug
Intrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery.
Intrauterine gel-injection therapyDrug
Intrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group( Intrauterine patients) do not apply intrauterine lavage therapy or intrauterine gel-injection therapy after surgery. |
| Intrauterine lavage therapy group | Experimental | Intrauterine lavage therapy group apply intrauterine lavage therapy after surgery. Receives: Drug: Intrauterine lavage therapy |
| Intrauterine gel-injection therapy group | Experimental | Intrauterine gel-injection therapy group apply intrauterine gel-injection therapy after surgery. Receives: Drug: Intrauterine gel-injection therapy |
| Healthy control group | No intervention | Healthy control group 1)have regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity.2) had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Measured: 1 year
Secondary outcomes (5)
Menstruation Pattern(Improvement or No Significant Change) of All Participants
A method similar to visual analogue scale(VAS) was employed for the evaluation of post-operative menstruation with 0 as amenorrhea and 100 as normal menstruation.
Measured: 1 year
Reduction of American Fertility Society adhesion score at Second-look
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: one year
Number of Participants With Pregnancy after operation
Measured: two years
Differences in distribution of reproductive tract bacteria between patients are before and after operation
Measured: one year
Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 May 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yuqing Chen, Deputy chief, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731689
- Sponsor's protocol ID
- Intrauterine adhesions
- Status last verified
- Nov 2018
- First submitted
- 3 Nov 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora
- ClinicalTrials.gov ID
- NCT03731689
- Acronym / sponsor ID
- Intrauterine adhesions
- Conditions
- Intrauterine Adhesions
- Keywords
- intrauterine lavage therapy, hysteroscopy, microbiome, uterine endometrial repair, intrauterine gel-injection therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Nov 2018 (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.
This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis.
Detailed description
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 intrauterine adhesion 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. Intrauterine adhesion separation surgery is the gold standard for the treatment of uterine adhesion. Although the success rate is as high as 95%, the patients with moderate or severe uterine adhesion have severe damage to the endometrial basement, poor regeneration of endometrial and gland, poor tolerance of endometrial and poor clinical prognosis. Even if all kinds of anti-adhesion measures are used comprehensively, the postoperative recurrence rate of patients with moderate and severe uterine adhesion is high.Therefore this study was conducted to investigate whether intrauterine lavage or intrauterine gel-injection therapy after surgery could reduce the recurrence of intrauterine adhesion, promote the endometrial growth and repair and improve the menstruation and reproductive prognosis for severe intrauterine adhesion, and we hypothesize that intrauterine adhesion may be related to changes in microbial flora in the reproductive tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group( Intrauterine patients) do not apply intrauterine lavage therapy or intrauterine gel-injection therapy after surgery. |
| Intrauterine lavage therapy group | Experimental | Drug: Intrauterine lavage therapyIntrauterine lavage therapy group apply intrauterine lavage therapy after surgery. |
| Intrauterine gel-injection therapy group | Experimental | Drug: Intrauterine gel-injection therapyIntrauterine gel-injection therapy group apply intrauterine gel-injection therapy after surgery. |
| Healthy control group | No intervention | –Healthy control group 1)have regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity.2) had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pre-operative adhesion score was ≥5
- The prior menstrual cycle was regular, and the sex hormone was normal
- Patients had fertility requirement
- Male semen examination showed normal
- 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
- Patients had no fertility requirement
- Patients(experimental group and control group) had male factor infertility
- 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 |
|---|---|---|
| Intrauterine lavage therapyIntrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery. | Drug | Intrauterine lavage therapy group |
| Intrauterine gel-injection therapyIntrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery. | Drug | Intrauterine gel-injection therapy group |
Primary outcome
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Time frame: 1 year
5 secondary outcomes
Menstruation Pattern(Improvement or No Significant Change) of All Participants
Time frame: 1 year
Reduction of American Fertility Society adhesion score at Second-look
Time frame: one year
Number of Participants With Pregnancy after operation
Time frame: two years
Differences in distribution of reproductive tract bacteria between patients are before and after operation
Time frame: one year
Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: Yes
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Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
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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.
Yuqing Chen, Deputy chief principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine lavage therapy and Intrauterine gel-injection therapy in people with Intrauterine Adhesions, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 6 Nov 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaling Guo, master (15622327162, 1106561876@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2018.