InfertilityNCT02680366
Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
A study testing collagen/ABMNC scaffold and Foley catheter balloon in people with Infertility and Asherman Syndrome, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This study evaluates the addition of collagen scaffold loaded with autologous bone marrow mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the treatment of severe asherman syndrome. 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
- Infertility, Asherman Syndrome
- What is being tested?
- collagen/ABMNC scaffold and Foley catheter balloon
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2016to 22 Jul 2022
- 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
- Having a clear desire to fertility;
- Infertility that is defined as a women fails to become pregnant after having a normal sex life for two years without contraception.
- Hysteroscopy examination confirmed intrauterine adhesions(patients who has at least one of the three symptoms which are amenorrhea, hypomenorrhea or infertility, and hysteroscopy or histologic diagnosis of intrauterine adhesions), meeting American Fertility Society diagnostic criteria Ⅱ-III;
- Normal ovarian function;
- Regular Menstrual cycles and menstruation is normal before abortion or curettage;
- BMI< 30 kg/m2;
- Sign a consent form;
- Follow the test plan and follow-up process.
Who cannot join
- Hereditary diseases;
- Simple thin endometrium with no uterine cavity adhesion;
- Simple Uterine scar formation with no uterine cavity adhesion after hysteroscopic adhesiolysis;
- Contraindications to bone marrow collection or assisted reproductive technology;
- History of malignant tumor;
- Other diseases associated with the uterus: uterine fibroids, severe adenomyosis, severe malformations of the uterus;
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- Abnormal blood coagulation, liver and kidney dysfunction, or other diseases which the researchers think may affect the study(such as: uncontrolled hypertension, diabetes, sexually transmitted diseases);
- With a positive urine pregnancy test；
- Participating in other clinical studies at the same time;
- Hysteroscopic adhesiolysis more than 3 times in the past.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Single-blind, Controlled Clinical Trial of Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
This study evaluates the addition of collagen scaffold loaded with autologous bone marrow mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter balloon.
Read the detailed description
Severe asherman syndrome will lead to infertility, and the most common method to treat asherman syndrome is operating to dissect adhesions. In order to prevent the postoperative re-adhesion, many physical isolation measures have been tried. However, they don't improve the microenvironment of endometrial regeneration. It's reported that bone marrow mononuclear cells have good effects on the functional recovery of injured uterus. This study will determine whether collagen scaffolds loaded with autologous bone marrow mononuclear cells will be more effective than Foley balloon catheters at treating infertile women with severe intrauterine adhesions who have taken hysteroscopic adhesiolysis. In addition, the study will be carried out in 2 centers, one is the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, the other is Changzhou Maternal and Child Health Care Hospital that is in Jiangsu Province.
- Conditions
- Infertility, Asherman Syndrome
- Being tested
- collagen/ABMNC scaffold, Foley catheter balloon
- Medical subject headings
- Infertility, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen/ABMNC scaffoldDevice
The patients will receive a bone marrow puncture to collect bone marrow cells which are used to isolation of ABMNCs. After that, hysteroscopic adhesiolysis will be done according to the patient's uterine adhesion. Then, the collagen/ABMNCs scaffold was covered on a Foley catheter balloon and placed into the uterine cavity. The catheter balloon was kept for 24 hours and then removed. Oral antibiotics were given to prevent infection in the second and third days after operation. 72 hours after the surgery, a vaginal speculum examinations will be done in order to make patients unknown about their arms. Estrogen will be administrated for 3 cycles to support the endometrial regeneration after the surgery. The clinical follow up will be done at 1, 3 and 6 months after the procedure.
Foley catheter balloonDevice
The patients will receive a sham bone marrow puncture which just has a local anesthesia and collects no bone marrow cells to isolation. After that, hysteroscopic adhesiolysis will be done according to the patient's uterine adhesion. And then, a Foley catheter balloon will be placed into the uterine cavity and kept for 72 hours before it is removed. Oral antibiotics were given to prevent infection in the second and third days after operation. Estrogen will be administrated for 3 cycles to support the endometrial regeneration after the surgery. The clinical follow up will be done at 1, 3 and 6 months after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| collagen/ABMNC scaffold | Experimental | collagen/ABMNC scaffold covered on Foley catheter balloon inserted after hysteroscopic adhesiolysis Receives: Device: collagen/ABMNC scaffold |
| Foley catheter balloon | Active comparator | Foley catheter balloon inserted after hysteroscopic adhesiolysis Receives: Device: Foley catheter balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
A successful clinical pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart activity and the size of the fetus is in consistent with the gestational week.
Measured: up to 24 months
Secondary outcomes (8)
Menstrual volumes and menstrual improvement:
PBAC scores in the third and sixth menstrual cycles after the initial adhesiolysis and PBAC scores increase compared to pre-operation
Measured: at 3 and 6 months post-operation
Maximal endometrial thickness
Measure the endometrial thickness during ovulation by ultrasound by the same trained medical sonographers at 3 and 6 months after surgery, comparing with pre-operation.
Measured: at 3 and 6 months post-operation
Re-adhesion rate at the second-look hysteroscopy
Measured: at 3 months post-operation
AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation
Measured: at 3 months post-operation
Miscarriage rate
Measured: up to 24 months
preterm birth rate
Measured: up to 24 months
ectopic pregnancy rate
Measured: up to 24 months
live birth rate
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study start22 Feb 2016
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- BMSCs group (BMSCs-scaffold plus Foley catheter) or control group (only Foley catheter).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Changzhou Maternal and Child Care Hospital
- Responsible party
- Principal investigator, Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yali Hu, MD,PhD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680366
- Sponsor's protocol ID
- 201600301
- Status last verified
- Nov 2022
- First submitted
- 30 Jan 2016
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Both the study protocol and the statistical analysis plan are available on request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Single-blind, Controlled Clinical Trial of Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
- ClinicalTrials.gov ID
- NCT02680366
- Acronym / sponsor ID
- 201600301
- Conditions
- Infertility, Asherman Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Changzhou Maternal and Child Care Hospital
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 11 Feb 2016 (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.
This study evaluates the addition of collagen scaffold loaded with autologous bone marrow mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter balloon.
Detailed description
Severe asherman syndrome will lead to infertility, and the most common method to treat asherman syndrome is operating to dissect adhesions. In order to prevent the postoperative re-adhesion, many physical isolation measures have been tried. However, they don't improve the microenvironment of endometrial regeneration. It's reported that bone marrow mononuclear cells have good effects on the functional recovery of injured uterus. This study will determine whether collagen scaffolds loaded with autologous bone marrow mononuclear cells will be more effective than Foley balloon catheters at treating infertile women with severe intrauterine adhesions who have taken hysteroscopic adhesiolysis. In addition, the study will be carried out in 2 centers, one is the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, the other is Changzhou Maternal and Child Health Care Hospital that is in Jiangsu Province.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- BMSCs group (BMSCs-scaffold plus Foley catheter) or control group (only Foley catheter).
| Arm | Type | Receives |
|---|---|---|
| collagen/ABMNC scaffold | Experimental | Device: collagen/ABMNC scaffoldcollagen/ABMNC scaffold covered on Foley catheter balloon inserted after hysteroscopic adhesiolysis |
| Foley catheter balloon | Active comparator | Device: Foley catheter balloonFoley catheter balloon inserted after hysteroscopic adhesiolysis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Having a clear desire to fertility;
- Infertility that is defined as a women fails to become pregnant after having a normal sex life for two years without contraception.
- Hysteroscopy examination confirmed intrauterine adhesions(patients who has at least one of the three symptoms which are amenorrhea, hypomenorrhea or infertility, and hysteroscopy or histologic diagnosis of intrauterine adhesions), meeting American Fertility Society diagnostic criteria Ⅱ-III;
- Normal ovarian function;
- Regular Menstrual cycles and menstruation is normal before abortion or curettage;
Key exclusion criteria (10 listed)
- Hereditary diseases;
- Simple thin endometrium with no uterine cavity adhesion;
- Simple Uterine scar formation with no uterine cavity adhesion after hysteroscopic adhesiolysis;
- Contraindications to bone marrow collection or assisted reproductive technology;
- History of malignant tumor;
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 |
|---|---|---|
| collagen/ABMNC scaffoldThe patients will receive a bone marrow puncture to collect bone marrow cells which are used to isolation of ABMNCs. After that, hysteroscopic adhesiolysis will be done according to the patient's uterine adhesion. Then, the collagen/ABMNCs scaffold was covered on a Foley catheter balloon and placed into the uterine cavity. The catheter balloon was kept for 24 hours and then removed. Oral antibiotics were given to prevent infection in the second and third days after operation. 72 hours after the surgery, a vaginal speculum examinations will be done in order to make patients unknown about their arms. Estrogen will be administrated for 3 cycles to support the endometrial regeneration after the surgery. The clinical follow up will be done at 1, 3 and 6 months after the procedure. | Device | collagen/ABMNC scaffold |
| Foley catheter balloonThe patients will receive a sham bone marrow puncture which just has a local anesthesia and collects no bone marrow cells to isolation. After that, hysteroscopic adhesiolysis will be done according to the patient's uterine adhesion. And then, a Foley catheter balloon will be placed into the uterine cavity and kept for 72 hours before it is removed. Oral antibiotics were given to prevent infection in the second and third days after operation. Estrogen will be administrated for 3 cycles to support the endometrial regeneration after the surgery. The clinical follow up will be done at 1, 3 and 6 months after the procedure. | Device | Foley catheter balloon |
Primary outcome
Ongoing pregnancy rate
Time frame: up to 24 months
A successful clinical pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart activity and the size of the fetus is in consistent with the gestational week.
8 secondary outcomes
Menstrual volumes and menstrual improvement:
Time frame: at 3 and 6 months post-operation
Maximal endometrial thickness
Time frame: at 3 and 6 months post-operation
Re-adhesion rate at the second-look hysteroscopy
Time frame: at 3 months post-operation
AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation
Time frame: at 3 months post-operation
Miscarriage rate
Time frame: up to 24 months
preterm birth rate
Time frame: up to 24 months
ectopic pregnancy rate
Time frame: up to 24 months
live birth rate
Time frame: up to 24 months
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 30 Nov 2022.
- Individual participant dataSharing planned: Yes. Both the study protocol and the statistical analysis plan are available on request.
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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.
Yali Hu, MD,PhD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen/ABMNC scaffold and Foley catheter balloon in people with Infertility and Asherman Syndrome, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 30 Nov 2022. 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?
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?
Ongoing pregnancy rate (time frame: up to 24 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 30 Nov 2022.