Intrauterine AdhesionNCT03329898
Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion
A study testing dried biological amnion graft, disposable balloon uterine stent and estradiol valerate tablets in people with Intrauterine Adhesion, run by Beijing Obstetrics and Gynecology Hospital at 1 site in China.
Trial summary
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- dried biological amnion graft, disposable balloon uterine stent and estradiol valerate tablets
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2017to 25 Nov 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- age 20-45 years.
- previously diagnostic hysteroscopy confirmed adhesion score ≧5， according to the American Fertility Society (AFS).
- complains of menstruation disorder and reproductive dysfunction.
- informed consent.
Who cannot join
- premature menopause,
- presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
- presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
- adhesions limited to the lower uterine cavity or the cervical canal.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing
Liu Zhen, MD, +8613718210767, fcyykyb@163.com
About this study
Official title: Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon and amniotic products can improve clinical outcomes? Therefore, this study was conducted.
Read the detailed description
The diaposable balloon uterine(a special intrauterine balloon) is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery. Another group, the diaposable balloon uterin and dried biological amnion will be inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery.Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
- Conditions
- Intrauterine Adhesion
- Being tested
- dried biological amnion graft, disposable balloon uterine stent, estradiol valerate tablets, dydrogesterone Tablets
- Keywords
- Asherman syndrome, uterine stent, hysteroscopy
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dried biological amnion graftProcedure or surgery
Also called uterine application of amnion membrance
dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .
disposable balloon uterine stentDevice
the disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus.
estradiol valerate tabletsDrug
Also called Progynova
oral estradiol valerate tablets, which can promote endometrial growth after operation.
dydrogesterone TabletsDrug
Also called Duphaston
oral dydrogesterone Tablets
| Study group | Role | What they receive |
|---|---|---|
| dried biological amnion graft | Experimental | dried biological amnion graft patients, who are with IUA, treated by uterine application of dried biological amnion graft + disposable balloon uterine stent + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. Receives: Procedure: dried biological amnion graft; Device: disposable balloon uterine stent; Drug: estradiol valerate tablets; Drug: dydrogesterone Tablets |
| disposable balloon uterine stent only | Sham comparator | disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent only + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. Receives: Device: disposable balloon uterine stent; Drug: estradiol valerate tablets; Drug: dydrogesterone Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
second diagnostic hysteroscopy
American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively
Measured: postoperation three months
Secondary outcomes (3)
pregnancy
the number of biochemical pregnancy or clinical pregnancy
Measured: postoperation one year
Menstruation Pattern
Amenorrhoea, hypomenorrhea, normal menstrual volume
Measured: postoperation three months
adhesion reformation
Adhesion is seen under direct vision by hysteroscopy
Measured: postoperation three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start31 Oct 2017
- Primary completion25 Oct 2018 (estimated)
- Study completion25 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Obstetrics and Gynecology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duan Hua, PhD, Study chair, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329898
- Sponsor's protocol ID
- No.4-20171020
- Status last verified
- Nov 2017
- First submitted
- 20 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
- ClinicalTrials.gov ID
- NCT03329898
- Acronym / sponsor ID
- No.4-20171020
- Conditions
- Intrauterine Adhesion
- Keywords
- Asherman syndrome, uterine stent, hysteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Obstetrics and Gynecology HospitalUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 25 Oct 2018 (estimated)
- Study completion
- 25 Nov 2018 (estimated)
- First posted
- 6 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.
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon and amniotic products can improve clinical outcomes? Therefore, this study was conducted.
Detailed description
The diaposable balloon uterine(a special intrauterine balloon) is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery. Another group, the diaposable balloon uterin and dried biological amnion will be inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery.Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dried biological amnion graft | Experimental | Procedure: dried biological amnion graft, Device: disposable balloon uterine stent, Drug: estradiol valerate tablets, Drug: dydrogesterone Tabletsdried biological amnion graft patients, who are with IUA, treated by uterine application of dried biological amnion graft + disposable balloon uterine stent + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
| disposable balloon uterine stent only | Sham comparator | Device: disposable balloon uterine stent, Drug: estradiol valerate tablets, Drug: dydrogesterone Tabletsdisposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent only + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 20-45 years.
- previously diagnostic hysteroscopy confirmed adhesion score ≧5， according to the American Fertility Society (AFS).
- complains of menstruation disorder and reproductive dysfunction.
- informed consent.
Key exclusion criteria (4 listed)
- premature menopause,
- presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
- presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
- adhesions limited to the lower uterine cavity or the cervical canal.
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 |
|---|---|---|
| dried biological amnion graftAlso: uterine application of amnion membrancedried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent . | Procedure or surgery | dried biological amnion graft |
| disposable balloon uterine stentthe disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus. | Device | disposable balloon uterine stent only, dried biological amnion graft |
| estradiol valerate tabletsAlso: Progynovaoral estradiol valerate tablets, which can promote endometrial growth after operation. | Drug | disposable balloon uterine stent only, dried biological amnion graft |
| dydrogesterone TabletsAlso: Duphastonoral dydrogesterone Tablets | Drug | disposable balloon uterine stent only, dried biological amnion graft |
Primary outcome
second diagnostic hysteroscopy
Time frame: postoperation three months
American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively
3 secondary outcomes
pregnancy
Time frame: postoperation one year
Menstruation Pattern
Time frame: postoperation three months
adhesion reformation
Time frame: postoperation three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- 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.
Duan Hua, PhD study chair
Beijing Obstetrics and Gynecology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dried biological amnion graft, disposable balloon uterine stent and estradiol valerate tablets in people with Intrauterine Adhesion, run by Beijing Obstetrics and Gynecology Hospital 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 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: status not confirmed, as of the sponsor's last update on 17 Nov 2017. 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. Some participants in this study may receive a placebo. 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 Zhu Ru, MD (13966636438, zhuru19790202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
second diagnostic hysteroscopy (time frame: postoperation three months). 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 17 Nov 2017.