Intrauterine AdhesionsNCT02496052
The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions
A study testing dried biological amnion graft, Foley balloon and estradiol valerate tablets+dydrogesterone Tablets in people with Intrauterine Adhesions, run by Beijing Obstetrics and Gynecology Hospital at 1 site in China.
Trial summary
To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Adhesions
- What is being tested?
- dried biological amnion graft, Foley balloon and estradiol valerate tablets+dydrogesterone 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
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jun 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20-40 years；
- previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA；
- 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, Beijing Municipality, 100006
Liu Zhen, M.D, +8613718210767, fcyykyb@163.com
About this study
Official title: The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions
To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.
Read the detailed description
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
- Conditions
- Intrauterine Adhesions
- Being tested
- dried biological amnion graft, Foley balloon, estradiol valerate tablets+dydrogesterone Tablets
- Keywords
- amnion graft, New biological barrier system
- 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 membrane
Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
Foley balloonDevice
Also called Device: Foley balloon Uterine application of Foley balloon
Device: Foley balloon Uterine application of Foley balloon
estradiol valerate tablets+dydrogesterone TabletsDrug
Also called Progynova+dydrogesterone
oral estradiol valerate tablets+dydrogesterone Tablets
| Study group | Role | What they receive |
|---|---|---|
| dried biological amnion graft | Experimental | patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. Receives: Procedure: dried biological amnion graft; Device: Foley balloon; Drug: estradiol valerate tablets+dydrogesterone Tablets |
| Foley catheter balloon only | Sham comparator | patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. Receives: Device: Foley balloon; Drug: estradiol valerate tablets+dydrogesterone Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
second diagnostic hysteroscopy
Measured: postoperation three to four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJan 2013
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Obstetrics and Gynecology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duan Hua, Ph.D, Study chair, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496052
- Sponsor's protocol ID
- NO.1-20140601
- Other IDs
- 2014-1-2112, zylx201406
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. doi: 10.1111/j.1447-0756.2006.00454.x.
PubMed 17100817Gan L, Duan H, Sun FQ, Xu Q, Tang YQ, Wang S. Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions. Int J Gynaecol Obstet. 2017 May;137(2):116-122. doi: 10.1002/ijgo.12112. Epub 2017 Mar 1.
PubMed 28170094
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions
- ClinicalTrials.gov ID
- NCT02496052
- Acronym / sponsor ID
- NO.1-20140601
- Conditions
- Intrauterine Adhesions
- Keywords
- amnion graft, New biological barrier system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Obstetrics and Gynecology HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Jul 2015 (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.
To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.
Detailed description
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
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dried biological amnion graft | Experimental | Procedure: dried biological amnion graft, Device: Foley balloon, Drug: estradiol valerate tablets+dydrogesterone Tabletspatients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
| Foley catheter balloon only | Sham comparator | Device: Foley balloon, Drug: estradiol valerate tablets+dydrogesterone Tabletspatients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 20-40 years；
- previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA；
- 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 membraneUterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane | Procedure or surgery | dried biological amnion graft |
| Foley balloonAlso: Device: Foley balloon Uterine application of Foley balloonDevice: Foley balloon Uterine application of Foley balloon | Device | Foley catheter balloon only, dried biological amnion graft |
| estradiol valerate tablets+dydrogesterone TabletsAlso: Progynova+dydrogesteroneoral estradiol valerate tablets+dydrogesterone Tablets | Drug | Foley catheter balloon only, dried biological amnion graft |
Primary outcome
second diagnostic hysteroscopy
Time frame: postoperation three to four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Results publication: PubMed 17100817Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. doi: 10.1111/j.1447-0756.2006.00454.x.
- Derived from this study: PubMed 28170094Gan L, Duan H, Sun FQ, Xu Q, Tang YQ, Wang S. Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions. Int J Gynaecol Obstet. 2017 May;137(2):116-122. doi: 10.1002/ijgo.12112. Epub 2017 Mar 1.
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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, Ph.D 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, Foley balloon and estradiol valerate tablets+dydrogesterone Tablets in people with Intrauterine Adhesions, 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 Jul 2015. 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 Wang Xin, MD (13681401510, wx_0327@126.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 to four months). 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 NCT02496052, which also lists 2 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 17 Jul 2015.