Intrauterine AdhesionNCT03353909
The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
A study testing new crosslinked hyaluronan gel in people with Intrauterine Adhesion, run by BioRegen Biomedical (Changzhou) Co., Ltd.
Trial summary
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- new crosslinked hyaluronan gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 15 Feb 2017
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
The inclusion criteria:
- Patients to be female, aged 18-45 years
- Without previous dilatation and curettage
- Undergoing dilatation and curettage for the current delayed miscarriage
- All participants should be with normal liver/rental function and without systemic disease
- Agree to use adequate forms of contraception throughout the study
- Be in good compliance with the follow-up examination according to the study protocol.
The exclusion criteria:
- Known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives
- Genital tract malformation
- Inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract
- Suspected genital tuberculosis
- Abnormal blood coagulation
- Medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness
- Acute or severe infection
- Autoimmune diseases.
About this study
Official title: The Efficacy of A New Crosslinked Hyaluronan Gel in the Prevention of Postoperative Intrauterine Adhesion After Dilatation and Curettage in Women With Delayed Miscarriage: A Prospective, Randomized, Controlled Trial
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.
Read the detailed description
Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage.
Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage.
Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation.
Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.
- Conditions
- Intrauterine Adhesion
- Being tested
- new crosslinked hyaluronan gel
- Keywords
- Intrauterine adhesion, Delayed miscarriage, hyaluronan gel
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new crosslinked hyaluronan gelDevice
Also called MateRegen Gel
At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | At the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula. Receives: Device: new crosslinked hyaluronan gel |
| Control | No intervention | At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intrauterine adhesion
The number of women with intrauterine adhesion
Measured: 3 months after dilatation and curettage
Secondary outcomes (5)
The adhesion scores of extent of uterine cavity involved
Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (<1/3 cavity with adhesion), 2 points (1/3-2/3 cavity with adhesion) and 4 points (>2/3 cavity with adhesion), high values represent worse outcome
Measured: 3 months after dilatation and curettage
The adhesion scores of type of adhesion
Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (filmy adhesion), 2 points (filmy \& dense adhesion) and 4 points (dense adhesion), high values represent worse outcome
Measured: 3 months after dilatation and curettage
The adhesion scores of menstrual pattern
Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 0 point (normal), 2 points (hypomenorrhea) and 4 points (amenorrhea), high values represent worse outcome
Measured: 3 months after dilatation and curettage
Cumulative adhesion score
The summed score of the adhesion scores of extent of uterine cavity involved, type of adhesion and menstrual pattern; range: 1-12 points, high values represent worse outcome
Measured: 3 months after dilatation and curettage
Severity
Graded according to cumulative adhesion score: Stage I (mild)(1-4 points), Stage II (moderate)(5-8 points) and Stage III (severe)(9-12 points).
Measured: 3 months after dilatation and curettage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Jul 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
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 Intrauterine AdhesionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioRegen Biomedical (Changzhou) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353909
- Sponsor's protocol ID
- FNL-2016-03
- Status last verified
- Nov 2017
- First submitted
- 10 Oct 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Wu L, Zhou Y, Fan X, Huang J, Wu J, Yu R, Lou J, Yang M, Yao Z, Xue M. New Crosslinked Hyaluronan Gel for the Prevention of Intrauterine Adhesions after Dilation and Curettage in Patients with Delayed Miscarriage: A Prospective, Multicenter, Randomized, Controlled Trial. J Minim Invasive Gynecol. 2019 Jan;26(1):94-99. doi: 10.1016/j.jmig.2018.03.032. Epub 2018 Apr 17.
PubMed 29678756
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of A New Crosslinked Hyaluronan Gel in the Prevention of Postoperative Intrauterine Adhesion After Dilatation and Curettage in Women With Delayed Miscarriage: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03353909
- Acronym / sponsor ID
- FNL-2016-03
- Conditions
- Intrauterine Adhesion
- Keywords
- Intrauterine adhesion, Delayed miscarriage, hyaluronan gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- BioRegen Biomedical (Changzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 27 Nov 2017 (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.
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.
Detailed description
Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage.
Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage.
Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation.
Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: new crosslinked hyaluronan gelAt the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula. |
| Control | No intervention | –At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| new crosslinked hyaluronan gelAlso: MateRegen GelAt the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity. | Device | Treatment |
Primary outcome
Incidence of intrauterine adhesion
Time frame: 3 months after dilatation and curettage
The number of women with intrauterine adhesion
5 secondary outcomes
The adhesion scores of extent of uterine cavity involved
Time frame: 3 months after dilatation and curettage
The adhesion scores of type of adhesion
Time frame: 3 months after dilatation and curettage
The adhesion scores of menstrual pattern
Time frame: 3 months after dilatation and curettage
Cumulative adhesion score
Time frame: 3 months after dilatation and curettage
Severity
Time frame: 3 months after dilatation and curettage
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 27 Nov 2017.
- Derived from this study: PubMed 29678756Li X, Wu L, Zhou Y, Fan X, Huang J, Wu J, Yu R, Lou J, Yang M, Yao Z, Xue M. New Crosslinked Hyaluronan Gel for the Prevention of Intrauterine Adhesions after Dilation and Curettage in Patients with Delayed Miscarriage: A Prospective, Multicenter, Randomized, Controlled Trial. J Minim Invasive Gynecol. 2019 Jan;26(1):94-99. doi: 10.1016/j.jmig.2018.03.032. Epub 2018 Apr 17.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing new crosslinked hyaluronan gel in people with Intrauterine Adhesion, run by BioRegen Biomedical (Changzhou) Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Nov 2017. 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?
Incidence of intrauterine adhesion (time frame: 3 months after dilatation and curettage). 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 NCT03353909, 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 27 Nov 2017.