Intrauterine AdhesionsNCT02132104
Efficiency of Amnion Graft to Prevent Intrauterine Adhesions After Hysteroscopic Surgery
A study testing Uterine application of amnion membrane, Foley balloon and Femoston in people with Intrauterine Adhesions, run by Capital Medical University at 2 sites in China.
Trial summary
The purpose of the study is to evaluate whether human amnion graft reduces the reformation of severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Adhesions
- What is being tested?
- Uterine application of amnion membrane, Foley balloon and Femoston
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2014to Nov 2016
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients scheduled for adhesiolysis of intrauterine adhesions
- patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions.
- Written, informed consent obtained.
Who cannot join
- ongoing pregnancy
- Peroperative fever or infections
- Malignancy
- Precious pelvic inflammatory disease
- Uterine fibroid (>3cm size)
- endometriosis
- Contraindications for anesthesia
- Not able to read and/or understand informed consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fu Xing Hospital, Capital Medical University
Beijing, 100038
Shanshan Zheng, 0086 10 88062032, fxyykjk@sina.com
Qin Zhong, 0086 10 88062944, fxyykjk@sina.com
Fu Xing Hospital, Capital Medical University
Beijing, 100038
Shanshan Zheng, 0086 10 88062032, fxyykjk@sina.com
Qin Zhong, 008610 88062944, fxyykjk@sina.com
About this study
Official title: Amnion Graft for Preventing Intrauterine Adhesions Following Hysteroscopic Surgery
The purpose of the study is to evaluate whether human amnion graft reduces the reformation of severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.
Read the detailed description
Background
IUA is a consequence of trauma to the endometrium, producing partial or complete obliteration in the uterine cavity and/or the cervical canal, resulting in conditions such as menstrual abnormalities, infertility, and recurrent pregnancy loss. The outcome of hysteroscopic adhesiolysis for IUA is significantly affected by recurrence of intrauterine adhesions. The IUA research should be directed toward reduction of adhesion reformation with a view to improve outcome.
The reformation of intrauterine adhesions appears to be directly related to the severity of the adhesions. It has been reported that the recurrence rate for intrauterine adhesions ranges from 3.1% to 23.5% among all cases of intrauterine adhesions and from 20% to 62.5% in those with severe adhesions.
In this study, considering the high recurrent rate in severe IUA, investigator will focus on severe IUA cases.
Up to now several strategies are commonly employed by various investigators after division of intrauterine adhesions:
- Physical barriers have been used to promote regeneration of the endometrium and prevention of adhesions. The physical barriers include an intrauterine device (IUD), a Foley catheter, a number of modifications of hyaluronic acid and Auto-cross-linked hyaluronic acid gel.
- Hormonal treatment has been used to promote regeneration of the endometrium.
- Antibiotic therapy has been used to prevent infection which is a potent trigger for adhesion formation/reformation.
- Various medications have been described to increase vascular flow to endometrium, such as asprin, nitroglycerine and sildenafil citrate.
There is published data (Amer et al, 2010), which based on a plot prospective, randomised, comparative study that grafting of either fresh or dried amnion is a promising adjunctive procedure for decreasing recurrence of adhesions and encouraging endometrial regeneration after hysteroscopic lysis of severe intrauterine adhesions. However, the study had a small number of patients, the valid conclusion can not be drawn.
In this study, the aim is to compare the safety and the efficacy of insertion of intrauterine balloon + hormonal treatment with or without grafting amnion to prevent intrauterine adhesion formation/reformation following division of intrauterine adhesions.
Study Design
Patients with severe IUA are enrolled according to the classification of intrauterine adhesion by American Fertility Society.
208 patients with severe IUA were chosen at random and divided equally into those who received amnion graft, following hysteroscopic adhesiolysis (treatment groups) and to those who did not receive the amnion graft (control groups).
Intervention
Following hysteroscopic adhesiolysis, patients will be randomised to have a Foley balloon with or without amnion graft into the uterine cavity. Hormones therapy has been used after surgical treatment both in treatment groups and control groups. A second look and a third look hysteroscopy will be performed about 4 and 12 weeks after the initial operative hysteroscopy. The amount of adhesions, if any, during the initial and reexamine hysteroscopies will be scored.
Power calculation
The investigators' retrospective pilot study data showed that the recurrent rate of severe IUA is around 30% in amnion treatment groups, and around 47.5% in control groups. According to these data, investigators calculated the sample sizes of this study by using Cochran-Mantel-Haenszel test with software PASS 11. Investigators will recruit 104 patients in each group.
Group sample sizes of 104 in group one and 104 in group two achieve 85% power to detect a difference between the group proportions of -0.2000. The group two proportion is 0.5000. The group one proportion is assumed to be 0.5000 under the null hypothesis and 0.3000 under the alternative hypothesis. The test statistic used is the two-sided Z test (unpooled). The significance level of the test was targeted at 0.0500. The significance level actually achieved by this design is not available.
Statistics
Safety and efficacy were evaluated by software NCSS-PASS, using Two Independent Proportions (Non-Null Case) Power Analysis.
- Conditions
- Intrauterine Adhesions
- Being tested
- Uterine application of amnion membrane, Foley balloon, Femoston
- Keywords
- Intrauterine adhesions, Asherman Syndrome, Amnion graft
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine application of amnion membraneProcedure or surgery
Also called Human amnion membrane
Uterine application of amnion membrane following hysteroscopic adhesiolysis.
Foley balloonDevice
Uterine application of Foley balloon
FemostonDrug
Also called Hormones
Hormones treatment after surgery.
| Study group | Role | What they receive |
|---|---|---|
| amnion graft in severe IUA | Experimental | patients, who are with severe IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis. Receives: Procedure: Uterine application of amnion membrane; Device: Foley balloon; Drug: Femoston |
| non-amnion graft in severe IUA | Sham comparator | patients, who are with severe IUA, treated by Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis. Receives: Device: Foley balloon; Drug: Femoston |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of intrauterine application of amnion membrane
patients treated by amnion membrane following their hysteroscopic procedure were followed for immediate and late adverse effect: fever, abnormal vaginal discharge, pelvic pain, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern.
Measured: 3 months
Secondary outcomes (1)
efficacy of intrauterine application of amnion graft in reducing adhesion formation following hysteroscopic adhesiolysis.
intrauterine adhesions were assessed and graded according to the American Fertility Society (AFS) score upon hysteroscopy follow up 4 and 12 weeks following initial treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Capital Medical 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XUEBING PENG, Capital Medical University
- Investigators
- TC Li, PhD, Study director, Hysteroscopic Center, Fu Xing HospitalXuebing Peng, MD, Principal investigator, Hysteroscopic Center, Fu Xing HospitalEnlan Xia, MD, Study chair, Hysteroscopic Center, Fu Xing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132104
- Sponsor's protocol ID
- CMU-FXH-14-06
- Status last verified
- Oct 2014
- First submitted
- 2 May 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.
PubMed 18406834Amer MI, Abd-El-Maeboud KH, Abdelfatah I, Salama FA, Abdallah AS. Human amnion as a temporary biologic barrier after hysteroscopic lysis of severe intrauterine adhesions: pilot study. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):605-11. doi: 10.1016/j.jmig.2010.03.019. Epub 2010 Jun 23.
PubMed 20576472Amer 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 17100817The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, mullerian anomalies and intrauterine adhesions. Fertil Steril. 1988 Jun;49(6):944-55. doi: 10.1016/s0015-0282(16)59942-7. No abstract available.
PubMed 3371491
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amnion Graft for Preventing Intrauterine Adhesions Following Hysteroscopic Surgery
- ClinicalTrials.gov ID
- NCT02132104
- Acronym / sponsor ID
- CMU-FXH-14-06
- Conditions
- Intrauterine Adhesions
- Keywords
- Intrauterine adhesions, Asherman Syndrome, Amnion graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 7 May 2014 (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.
The purpose of the study is to evaluate whether human amnion graft reduces the reformation of severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.
Detailed description
Background
IUA is a consequence of trauma to the endometrium, producing partial or complete obliteration in the uterine cavity and/or the cervical canal, resulting in conditions such as menstrual abnormalities, infertility, and recurrent pregnancy loss. The outcome of hysteroscopic adhesiolysis for IUA is significantly affected by recurrence of intrauterine adhesions. The IUA research should be directed toward reduction of adhesion reformation with a view to improve outcome.
The reformation of intrauterine adhesions appears to be directly related to the severity of the adhesions. It has been reported that the recurrence rate for intrauterine adhesions ranges from 3.1% to 23.5% among all cases of intrauterine adhesions and from 20% to 62.5% in those with severe adhesions.
In this study, considering the high recurrent rate in severe IUA, investigator will focus on severe IUA cases.
Up to now several strategies are commonly employed by various investigators after division of intrauterine adhesions:
- Physical barriers have been used to promote regeneration of the endometrium and prevention of adhesions. The physical barriers include an intrauterine device (IUD), a Foley catheter, a number of modifications of hyaluronic acid and Auto-cross-linked hyaluronic acid gel.
- Hormonal treatment has been used to promote regeneration of the endometrium.
- Antibiotic therapy has been used to prevent infection which is a potent trigger for adhesion formation/reformation.
- Various medications have been described to increase vascular flow to endometrium, such as asprin, nitroglycerine and sildenafil citrate.
There is published data (Amer et al, 2010), which based on a plot prospective, randomised, comparative study that grafting of either fresh or dried amnion is a promising adjunctive procedure for decreasing recurrence of adhesions and encouraging endometrial regeneration after hysteroscopic lysis of severe intrauterine adhesions. However, the study had a small number of patients, the valid conclusion can not be drawn.
In this study, the aim is to compare the safety and the efficacy of insertion of intrauterine balloon + hormonal treatment with or without grafting amnion to prevent intrauterine adhesion formation/reformation following division of intrauterine adhesions.
Study Design
Patients with severe IUA are enrolled according to the classification of intrauterine adhesion by American Fertility Society.
208 patients with severe IUA were chosen at random and divided equally into those who received amnion graft, following hysteroscopic adhesiolysis (treatment groups) and to those who did not receive the amnion graft (control groups).
Intervention
Following hysteroscopic adhesiolysis, patients will be randomised to have a Foley balloon with or without amnion graft into the uterine cavity. Hormones therapy has been used after surgical treatment both in treatment groups and control groups. A second look and a third look hysteroscopy will be performed about 4 and 12 weeks after the initial operative hysteroscopy. The amount of adhesions, if any, during the initial and reexamine hysteroscopies will be scored.
Power calculation
The investigators' retrospective pilot study data showed that the recurrent rate of severe IUA is around 30% in amnion treatment groups, and around 47.5% in control groups. According to these data, investigators calculated the sample sizes of this study by using Cochran-Mantel-Haenszel test with software PASS 11. Investigators will recruit 104 patients in each group.
Group sample sizes of 104 in group one and 104 in group two achieve 85% power to detect a difference between the group proportions of -0.2000. The group two proportion is 0.5000. The group one proportion is assumed to be 0.5000 under the null hypothesis and 0.3000 under the alternative hypothesis. The test statistic used is the two-sided Z test (unpooled). The significance level of the test was targeted at 0.0500. The significance level actually achieved by this design is not available.
Statistics
Safety and efficacy were evaluated by software NCSS-PASS, using Two Independent Proportions (Non-Null Case) Power Analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amnion graft in severe IUA | Experimental | Procedure: Uterine application of amnion membrane, Device: Foley balloon, Drug: Femostonpatients, who are with severe IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis. |
| non-amnion graft in severe IUA | Sham comparator | Device: Foley balloon, Drug: Femostonpatients, who are with severe IUA, treated by Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients scheduled for adhesiolysis of intrauterine adhesions
- patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions.
- Written, informed consent obtained.
Key exclusion criteria (8 listed)
- ongoing pregnancy
- Peroperative fever or infections
- Malignancy
- Precious pelvic inflammatory disease
- Uterine fibroid (>3cm size)
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 |
|---|---|---|
| Uterine application of amnion membraneAlso: Human amnion membraneUterine application of amnion membrane following hysteroscopic adhesiolysis. | Procedure or surgery | amnion graft in severe IUA |
| Foley balloonUterine application of Foley balloon | Device | amnion graft in severe IUA, non-amnion graft in severe IUA |
| FemostonAlso: HormonesHormones treatment after surgery. | Drug | amnion graft in severe IUA, non-amnion graft in severe IUA |
Primary outcome
safety of intrauterine application of amnion membrane
Time frame: 3 months
patients treated by amnion membrane following their hysteroscopic procedure were followed for immediate and late adverse effect: fever, abnormal vaginal discharge, pelvic pain, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern.
1 secondary outcome
efficacy of intrauterine application of amnion graft in reducing adhesion formation following hysteroscopic adhesiolysis.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Background: PubMed 18406834Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.
- Background: PubMed 20576472Amer MI, Abd-El-Maeboud KH, Abdelfatah I, Salama FA, Abdallah AS. Human amnion as a temporary biologic barrier after hysteroscopic lysis of severe intrauterine adhesions: pilot study. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):605-11. doi: 10.1016/j.jmig.2010.03.019. Epub 2010 Jun 23.
- Background: 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.
- Background: PubMed 3371491The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, mullerian anomalies and intrauterine adhesions. Fertil Steril. 1988 Jun;49(6):944-55. doi: 10.1016/s0015-0282(16)59942-7. No abstract available.
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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.
TC Li, PhD study director
Hysteroscopic Center, Fu Xing Hospital
Xuebing Peng, MD principal investigator
Hysteroscopic Center, Fu Xing Hospital
Enlan Xia, MD study chair
Hysteroscopic Center, Fu Xing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine application of amnion membrane, Foley balloon and Femoston in people with Intrauterine Adhesions, run by Capital Medical University at 2 sites 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 3 inclusion and 8 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 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Xuebing Peng, MD (008613901297392, peng_xue_bing@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of intrauterine application of amnion membrane (time frame: 3 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 NCT02132104, which also lists 4 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 21 Oct 2014.