Intrauterine AdhesionNCT05475756
Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis
A study testing Intrauterine Biological Barrier and Intrauterine Adhesion Barrier Gel in people with Intrauterine Adhesion, run by Beijing Tiantan Hospital at 6 sites in China.
Trial summary
To evaluate the safety and efficacy of Intrauterine Biological Barrier developed and produced by Chengdu TopRegMed Medical Technology Co., Ltd on postoperative adhesion after Hysteroscopic Adhesiolysis. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Intrauterine Biological Barrier and Intrauterine Adhesion Barrier Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 6 sitesChina
- Study dates
- 25 Feb 2022to 23 May 2025
- 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
- No healthy volunteers
- Adult
Who may be able to join
- （1）Age, yr20-40 (including boundary value), Female
- （2）Normal ovarian reserve function (FSH<10U/ml，AMH>2ng/ml)
- （3）Who suffered from moderate to severe intrauterine adhesions (AFS ≥ 5 points) diagnosed by hysteroscopy, and prepared to be treated by Hysteroscopic adhesiolysis
- （4）Both husband and wife have fertility intention during treatment
- （5）Accept to treatment and follow-up visits, Sign the ICF
Who cannot join
- （1）Severe systemic diseases, contraindications of surgical and cycle
- （2）Inflammation of reproductive tract, genital tuberculosis, pelvic infection, tumor of reproductive organs
- （3）Systemic diseases cause uterine bleeding
- （4）Allergic to hyaluronic acid or components
- （5）Allergic to swine sources medical device, or refuse to swine sources medical device for religious, ethnic and other reasons
- （6）Insufficient uterine cavity volume after Hysteroscopic adhesiolysis to place Intrauterine Biological Barrier or inject Intrauterine Adhesion Barrier Gel
Show all 10Show fewer
- （7）Involved other clinical trial before Hysteroscopic adhesiolysis in 3 months or during the trail
- （8）Unable to tolerate anesthesia
- （9）Estrogen medicine was taken within 30 days of Hysteroscopic adhesiolysis
- （10）Other inadequacy patient assessed by the researchers
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Qi Zhang
Qi Zhang
- Not yet recruiting
Guangzhou First people's Hospital
Guangzhou, Guangdong
Hao Zhang
Hao Zhang
- Not yet recruiting
Anhui Provincial Hosptial
Hefei, Anhui
Ting Gao
Ting Gao
- Not yet recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu
Shunyu Hou
Shunyu Hou
- Not yet recruiting
Tangdu Hospital
Xi’an, Shanxi
Xifeng Xiao
Xifeng Xiao
- Not yet recruiting
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian
Feifeng Shi
Feifeng Shi
About this study
Official title: Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis: a Prospective, Multicentre, Randomized, Positive Parallel Controlled, Non-inferiority, Clinical Trail
To evaluate the safety and efficacy of Intrauterine Biological Barrier developed and produced by Chengdu TopRegMed Medical Technology Co., Ltd on postoperative adhesion after Hysteroscopic Adhesiolysis.
Read the detailed description
This study is a prospective, multicenter, randomized, parallel positive-control, non-inferior clinical trial, with the purpose to evaluate the efficacy and safety of Intrauterine Biological Barrier for the prevention or reduction of intrauterine adhesions after Hysteroscopic Adhesiolysis.
The trial will be conducted at six clinical centers with 264 subjects who meet all the inclusion/ exclusion criteria. Subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Subjects in the test group were treated with Intrauterine Biological Barrier (IBB) made by Chengdu TopRegMed Medical Technology Co. , Ltd. , while the patients in the positive control group were treated with commercially approved Intrauterine Adhesion Barrier Gel for uterine cavity made by Changzhou Bioregen biopharmaceutical Co. , Ltd. .
Subjects will be followed up for 12 months (360 days ± 30 days) after implantation. 73-days (± 12 days) after operation, the safety and effectiveness of IBB will be evaluated by demonstrating non-inferiority to commercially approved gel. If test group is non-inferiority, further study will be performed to explore whether the safety and effectiveness of the IBB is better than the control group in the aspect of the recurrence rate of intrauterine adhesion, types of intrauterine adhesion, postoperative endometrial repair, menstrual recovery and 1-year pregnancy rate.
- Conditions
- Intrauterine Adhesion
- Being tested
- Intrauterine Biological Barrier, Intrauterine Adhesion Barrier Gel
- Keywords
- Endometrium, Adhesion, Postoperative adhesion, Hysteroscopy, Biological Barrier, Adhesion prevention, Infertility, Hysteroscopic Adhesiolysis
- Medical subject headings
- Gynatresia, Tissue Adhesions, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine Biological BarrierDevice
after Hysteroscopic adhesiolysis，use of Intrauterine Biological Barrier to repair uterine cavity
Intrauterine Adhesion Barrier GelDevice
after Hysteroscopic adhesiolysis，use of Intrauterine Adhesion Barrier Gel to repair uterine cavity
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Material：Small intestinal submucosa Specifications：A、B、C、D、E Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency：one time after the operation Duration：Single-use Receives: Device: Intrauterine Biological Barrier |
| Control Group | Active comparator | Material: auto-crosslinked HA gel Specifications: 1 ml, 1.25 ml, 1.5 ml, 1.75 ml, 2 ml, 2.25 ml, 2.5 ml, 2.75 ml, 3 ml, 3.25 ml, 3.75 ml, 4 ml, 4.25 ml, 4.5 ml, 5 ml, 6 ml, 8ml Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency：one time after the operation Duration：Single-use Receives: Device: Intrauterine Adhesion Barrier Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate
At second-look hysteroscopy after Hysteroscopic adhesiolysis, the effective rate (%) = (number of cured + number of apparent effect)/total number in the group × 100%
Measured: Day 73±12
Secondary outcomes (7)
Recurrence rate of adhesions
The Presence of adhesions was determined at second-look hysteroscopy after Hysteroscopic adhesiolysis, and the recurrence rate of adhesions (%) = number of adhesion reoccurrence/total number in the group × 100%
Measured: Day 73±12
Extent of uterine adhesions
The degree of uterine adhesions was assessed intraoperatively and at the second-look hysteroscopy with reference to the ESGE (European Society for Gynecological Endoscopy) criteria
Measured: Day 73±12
Endometrial improvement
Endometrial thickness in millimeter and change values in millimeter by Ultrasonic Diagnostic Equipment Transvaginal Ultrasonic Probe Head at screening and visit 4
Measured: Day -7 to day 1, Day 100±10
Time of menstrual recovery
Time to first menstruation after Hysteroscopic adhesiolysis
Measured: Day 73±12
Duration of Menstrual recovery
Days of menstrual duration
Measured: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Menstrual blood volume
Record and evaluate by Pictorial Blood Loss Assessment Chart (PBAC)
Measured: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Pregnancy rate after operation 1year
Pregnancy rate (%) = number of pregnancies in the group/total number in the group × 100%
Measured: Day 360±30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start25 Feb 2022
- Primary completion24 May 2024 (estimated)
- Study completion23 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhangzhou Municipal Hospital of Fujian Province, Guangzhou First People's Hospital, Tang-Du Hospital, Suzhou Municipal Hospital, Anhui Provincial Hospital
- Responsible party
- Principal investigator, Limin Feng, Beijing Tiantan Hospital
- Investigators
- Limin Feng, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475756
- Sponsor's protocol ID
- RKM-GPSIS-CTP202201
- Status last verified
- Jul 2022
- First submitted
- 7 Jun 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing, only data collection and filling into paper CRF by each site
Publications
March CM. Management of Asherman's syndrome. Reprod Biomed Online. 2011 Jul;23(1):63-76. doi: 10.1016/j.rbmo.2010.11.018. Epub 2010 Dec 4.
PubMed 21549641Yu 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 18406834The 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 3371491Leone FP, Timmerman D, Bourne T, Valentin L, Epstein E, Goldstein SR, Marret H, Parsons AK, Gull B, Istre O, Sepulveda W, Ferrazzi E, Van den Bosch T. Terms, definitions and measurements to describe the sonographic features of the endometrium and intrauterine lesions: a consensus opinion from the International Endometrial Tumor Analysis (IETA) group. Ultrasound Obstet Gynecol. 2010 Jan;35(1):103-12. doi: 10.1002/uog.7487.
PubMed 20014360Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x.
PubMed 2400752AAGL Elevating Gynecologic Surgery. AAGL practice report: practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy (ESGE). Gynecol Surg. 2017;14(1):6. doi: 10.1186/s10397-017-1007-3. Epub 2017 May 1. No abstract available.
PubMed 28603474Kong D, Zhang L, Xu X, Zhang J, Li Y, Huang X. Small Intestine Submucosa Is a Potential Material for Intrauterine Adhesions Treatment in a Rat Model. Gynecol Obstet Invest. 2018;83(5):499-507. doi: 10.1159/000479086. Epub 2017 Jul 20.
PubMed 28723687Zhang X, Qiu J, Ding Y, Sun L, Hua K. Single port laparoscopy combined with vaginal cervicovaginal reconstruction in a patient with congenital atresia of the cervix. Fertil Steril. 2020 Mar;113(3):681-682. doi: 10.1016/j.fertnstert.2019.11.011.
PubMed 32192600Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.
PubMed 23932377Amer 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 20576472
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis: a Prospective, Multicentre, Randomized, Positive Parallel Controlled, Non-inferiority, Clinical Trail
- ClinicalTrials.gov ID
- NCT05475756
- Acronym / sponsor ID
- RKM-GPSIS-CTP202201
- Conditions
- Intrauterine Adhesion
- Keywords
- Endometrium, Adhesion, Postoperative adhesion, Hysteroscopy, Biological Barrier, Adhesion prevention, Infertility, Hysteroscopic Adhesiolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Zhangzhou Municipal Hospital of Fujian Province, Guangzhou First People's Hospital, Tang-Du Hospital, Suzhou Municipal Hospital, Anhui Provincial Hospital
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 24 May 2024 (estimated)
- Study completion
- 23 May 2025 (estimated)
- First posted
- 27 Jul 2022 (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.
To evaluate the safety and efficacy of Intrauterine Biological Barrier developed and produced by Chengdu TopRegMed Medical Technology Co., Ltd on postoperative adhesion after Hysteroscopic Adhesiolysis.
Detailed description
This study is a prospective, multicenter, randomized, parallel positive-control, non-inferior clinical trial, with the purpose to evaluate the efficacy and safety of Intrauterine Biological Barrier for the prevention or reduction of intrauterine adhesions after Hysteroscopic Adhesiolysis.
The trial will be conducted at six clinical centers with 264 subjects who meet all the inclusion/ exclusion criteria. Subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Subjects in the test group were treated with Intrauterine Biological Barrier (IBB) made by Chengdu TopRegMed Medical Technology Co. , Ltd. , while the patients in the positive control group were treated with commercially approved Intrauterine Adhesion Barrier Gel for uterine cavity made by Changzhou Bioregen biopharmaceutical Co. , Ltd. .
Subjects will be followed up for 12 months (360 days ± 30 days) after implantation. 73-days (± 12 days) after operation, the safety and effectiveness of IBB will be evaluated by demonstrating non-inferiority to commercially approved gel. If test group is non-inferiority, further study will be performed to explore whether the safety and effectiveness of the IBB is better than the control group in the aspect of the recurrence rate of intrauterine adhesion, types of intrauterine adhesion, postoperative endometrial repair, menstrual recovery and 1-year pregnancy rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Intrauterine Biological BarrierMaterial：Small intestinal submucosa Specifications：A、B、C、D、E Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency：one time after the operation Duration：Single-use |
| Control Group | Active comparator | Device: Intrauterine Adhesion Barrier GelMaterial: auto-crosslinked HA gel Specifications: 1 ml, 1.25 ml, 1.5 ml, 1.75 ml, 2 ml, 2.25 ml, 2.5 ml, 2.75 ml, 3 ml, 3.25 ml, 3.75 ml, 4 ml, 4.25 ml, 4.5 ml, 5 ml, 6 ml, 8ml Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency：one time after the operation Duration：Single-use |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- （1）Age, yr20-40 (including boundary value), Female
- （2）Normal ovarian reserve function (FSH<10U/ml，AMH>2ng/ml)
- （3）Who suffered from moderate to severe intrauterine adhesions (AFS ≥ 5 points) diagnosed by hysteroscopy, and prepared to be treated by Hysteroscopic adhesiolysis
- （4）Both husband and wife have fertility intention during treatment
- （5）Accept to treatment and follow-up visits, Sign the ICF
Key exclusion criteria (10 listed)
- （1）Severe systemic diseases, contraindications of surgical and cycle
- （2）Inflammation of reproductive tract, genital tuberculosis, pelvic infection, tumor of reproductive organs
- （3）Systemic diseases cause uterine bleeding
- （4）Allergic to hyaluronic acid or components
- （5）Allergic to swine sources medical device, or refuse to swine sources medical device for religious, ethnic and other reasons
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 |
|---|---|---|
| Intrauterine Biological Barrierafter Hysteroscopic adhesiolysis，use of Intrauterine Biological Barrier to repair uterine cavity | Device | Experimental Group |
| Intrauterine Adhesion Barrier Gelafter Hysteroscopic adhesiolysis，use of Intrauterine Adhesion Barrier Gel to repair uterine cavity | Device | Control Group |
Primary outcome
Effective rate
Time frame: Day 73±12
At second-look hysteroscopy after Hysteroscopic adhesiolysis, the effective rate (%) = (number of cured + number of apparent effect)/total number in the group × 100%
7 secondary outcomes
Recurrence rate of adhesions
Time frame: Day 73±12
Extent of uterine adhesions
Time frame: Day 73±12
Endometrial improvement
Time frame: Day -7 to day 1, Day 100±10
Time of menstrual recovery
Time frame: Day 73±12
Duration of Menstrual recovery
Time frame: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Menstrual blood volume
Time frame: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Pregnancy rate after operation 1year
Time frame: Day 360±30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Background: PubMed 21549641March CM. Management of Asherman's syndrome. Reprod Biomed Online. 2011 Jul;23(1):63-76. doi: 10.1016/j.rbmo.2010.11.018. Epub 2010 Dec 4.
- 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 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.
- Background: PubMed 20014360Leone FP, Timmerman D, Bourne T, Valentin L, Epstein E, Goldstein SR, Marret H, Parsons AK, Gull B, Istre O, Sepulveda W, Ferrazzi E, Van den Bosch T. Terms, definitions and measurements to describe the sonographic features of the endometrium and intrauterine lesions: a consensus opinion from the International Endometrial Tumor Analysis (IETA) group. Ultrasound Obstet Gynecol. 2010 Jan;35(1):103-12. doi: 10.1002/uog.7487.
- Background: PubMed 2400752Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x.
- Background: PubMed 28603474AAGL Elevating Gynecologic Surgery. AAGL practice report: practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy (ESGE). Gynecol Surg. 2017;14(1):6. doi: 10.1186/s10397-017-1007-3. Epub 2017 May 1. No abstract available.
- Results publication: PubMed 28723687Kong D, Zhang L, Xu X, Zhang J, Li Y, Huang X. Small Intestine Submucosa Is a Potential Material for Intrauterine Adhesions Treatment in a Rat Model. Gynecol Obstet Invest. 2018;83(5):499-507. doi: 10.1159/000479086. Epub 2017 Jul 20.
- Results publication: PubMed 32192600Zhang X, Qiu J, Ding Y, Sun L, Hua K. Single port laparoscopy combined with vaginal cervicovaginal reconstruction in a patient with congenital atresia of the cervix. Fertil Steril. 2020 Mar;113(3):681-682. doi: 10.1016/j.fertnstert.2019.11.011.
- Results publication: PubMed 23932377Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.
- Results publication: 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.
- Individual participant dataSharing planned: No. No data sharing, only data collection and filling into paper CRF by each site
Related trials for Intrauterine Adhesion
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Recruiting
Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Intrauterine Adhesion
Recruiting
To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial
Intrauterine Adhesion, Intrauterine Adhesions
Not yet recruiting
Clinical Study of i-PRF Intrauterine Perfusion for Endometrial Regeneration and Repair in Moderate to Severe Intrauterine Adhesions
Intrauterine Adhesions
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.
Limin Feng principal investigator
Beijing Tiantan Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Biological Barrier and Intrauterine Adhesion Barrier Gel in people with Intrauterine Adhesion, run by Beijing Tiantan Hospital at 6 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 5 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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 Limin Feng (18911281961, Lucyfeng1966@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate (time frame: Day 73±12). 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 NCT05475756, which also lists 10 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 27 Jul 2022.