Intrauterine AdhesionNCT05003869
Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions
A study testing Scar tissue is removed in people with Intrauterine Adhesion and Scar, run by Lili Cao at 1 site in China.
Trial summary
TCRA is an important surgical method to restore normal menstrual cycle and improve the outcome of pregnancy.However, postoperative intrauterine adhesion, uterine cavity deformation and difficulty in normal intimal growth seriously affect the efficacy of surgery. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Adhesion, Scar
- What is being tested?
- Scar tissue is removed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2021to 31 May 2024
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consensus of Chinese Experts on the Clinical Diagnosis and Treatment of Intrauterine Adhesions, i.e., patients with previous history of induced abortion and other intrauterine operations, accompanied by periodical abdominal pain, fewmenorrhea, amenorrhea, recurrent abortion, infertility, and uterine adhesions found by hysteroscopy, who have fertility requirements;
- According to the American Reproductive Society prognostic classification, the AFS score was moderate to severe intrauterine adhesions, that is, the score range was 5-12 points;
- Patients ranged in age from 18 to 42 years old;
- normal endocrine function and ovulation;
- Patients had comprehensive clinical data and were followed up after surgery.
Who cannot join
- Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction and other systemic diseases;
- Patients who recently received female genital surgery or underwent high uterine flexion and were unable to receive hysteroscopy and surgical treatment;
- Amenorrhea, recurrent abortion and infertility caused by other factors such as neuro-endocrine system disorders or congenital abnormalities of reproductive structure and development;
- Patients with allergic reaction to estrogen and other drugs;
- Severe abnormal semen of the spouse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Shandong Qianfoshan Hospital
Jinan, Shandong, 250014
Lili Cao, qykyc309@163.com
Yingchun Ma
About this study
TCRA is an important surgical method to restore normal menstrual cycle and improve the outcome of pregnancy.However, postoperative intrauterine adhesion, uterine cavity deformation and difficulty in normal intimal growth seriously affect the efficacy of surgery. A large number of existing studies have shown that even after surgical treatment, women with a history of IUA are still at a reproductive disadvantage.Whether scar tissue plays a role in these influencing factors? At present, there is a variety of surgical methods, and there is no clear guideline consensus on how to deal with intrauterine scar tissue during surgery.
Read the detailed description
Intrauterine adhesions (IUA) are pathological symptoms of endometrial basal layer damage, fibrous tissue formation and tissue bridge between uterine walls caused by a variety of reasons.In recent years, with the increase of uterine operations such as hysterotomy and cesarean section, the incidence of IUA has been increasing year by year.IUA is mainly manifested by reduced menstrual volume, amenorrhea, recurrent abortion, infertility and abnormal implantation of embryos, etc., which poses a great threat to the health and quality of life of patients.Transcervieal resection of adhesions (TCRA) is a targeted method to separate intrauterine adhesions under direct vision and basically restore the morphology of the intrauterine cavity. It is an important surgical method to improve the pregnancy outcome.However, a large number of existing studies have shown that women with a history of IUA remain at a reproductive disadvantage even after surgical treatment.
Based on the current situation, the investigators have designed this topic, to conduct a study on TCRA intraoperative scar tissue to remove the necessity of clinical and basic research, explore the scar tissue resection or not for the clinical curative effect and the effect of combined tissue morphology, molecular biology research, for TCRA intraoperative how to deal with the scar tissue provide a certain amount of practice and theory basis.
Estrogen receptor (e-r) and progesterone receptor (P - R) is located in the nucleus, when the receptor and hormones to form complexes, again in the form of activation combined into specific areas of the chromosome, gene activation, synthesis of new DNA transcription, and synthesis of new proteins, through the biological function of protein regulating cell growth and metabolism.Specifically, they participate in the reconstruction and regeneration of endometrial blood vessels and cells.The number and functional status of hormone receptors determine the local levels of estrogen and progesterone that can exert biological effects. If the expression of E-R and P-R is reduced or the function is abnormal, the sensitivity and reactivity of endometrium to hormones will be directly reduced, and the endometrial growth will be affected.
The treatment of IUA is mainly based on direct separation of the adhesive tissue, supplemented by the corresponding hormone or cytokine therapy.Among them, estrogen is widely used.On the one hand, it plays a corresponding role by binding with receptors; on the other hand, it affects the fibrinogen and extracellular matrix deposition by regulating the expression of TGF-β or MMP-9, thus participating in the occurrence of intrauterine adhesions.
Studies have found that there is a certain correlation between transforming growth factor-β1 (TGF-β1) and the pathogenesis of IUA. TGF-β1 is a kind of cytokine that is synthesized and secreted by lymphocytes, macrophages, platelets and other cells and can regulate cell growth and differentiation, belonging to the TGF family.It can promote tissue fibrosis and extracellular matrix production, and can increase the amount of fibronectin and collagen.However, a number of studies have confirmed that inhibiting the expression of TGF-β1 or reducing its activity can effectively reduce the degree of fibrosis in liver, kidney and other tissues.
- Conditions
- Intrauterine Adhesion, Scar
- Being tested
- Scar tissue is removed
- Medical subject headings
- Gynatresia, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar tissue is removedProcedure or surgery
Also called No scar tissue is removed
The patients were divided into two groups according to whether the scar tissue was removed during TCRA operation: study group: resection of uterine scar tissue during TCRA operation;In the control group, the scar tissue covering the anterior, posterior and lateral walls of the uterine cavity was ploughed longitudinally into several narrow strips using needle-like electrodes, and the scar tissue was not excised.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative resection of intrauterine scar tissue by TCRA | Experimental | Study group: patients took the bladder lithotomy position, routinely disinfected vulva and vagina, and laid sterile towel and sheet.pliers Clamp the front lip of the cervix, explore the depth of the uterine cavity, dilate the cervical canal one by one, place the endoscopy, and examine the uterine cavity.After the scar tissue contracted on one side, the scar tissue was disintegrated at the boundary between the intima and scar tissue. The scar tissue was removed with the annular electrode, and a balloon was placed after surgery to prevent re-adhesion.Complete adhesion release is defined as a return to normal shape of the uterine cavity with bilateral uterine angles exposed. Receives: Procedure: Scar tissue is removed |
| No scar tissue resection group | No intervention | During the operation, the scar tissue covering the anterior, posterior and lateral walls of the uterine cavity was ploughed longitudinally into several narrow strips with needle-like electrodes, and scar tissue was not excised. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The menstrual chart records changes in menstrual volume
Menstrual chart records the amount of menstruation before and after surgery:Menstrual volume is basically normal;Menstrual volume increased compared with preoperative;Still amenorrhea or menstrual volume is not increased
Measured: 1 to 3 months before surgery and the first month after the operation
Preoperative and postoperative changes in endometrial thickness were recorded by Doppler ultrasonography.
Ultrasound was used to record endometrial thickness before and 2 weeks after the first operation. The second hysteroscopy was performed 3-7 days after the first clean menstruation after the first operation, and ultrasound was performed again 2 weeks after the operation to record the data and compare the endometrial thickness of each group.
Measured: Ultrasound examinations were performed before and 2 weeks after the first operation, and 2 weeks after the second operation
Preoperative and postoperative changes of intrauterine adhesions were recorded according to the American Fertility Society score in 1988: mild :1 ~ 4; Moderate: 5-8; Severe: 9-12 points
The operation time was within 3-7 days after menstruation (surgery could be performed at any time after excluding pregnancy for amenorrhea). Preoperative hysteroscopy scores and surgical procedures were all performed by the same surgeon.Intrauterine adhesions were measured using the 1988 American Fertility Society (AFS) score.
Three to seven days after the first menstrual cleanness, the patient was admitted to the hospital for hysteroscopic reexamination. During hysteroscopy, the intrauterine adhesion and intimal recovery of the patient were explored.
Measured: The first operation time is 3-7 days after menstruation (excluding amenorrhea pregnancy can be operated at any time). The second operation was performed 1 month after the first operation
Secondary outcomes (1)
Ultrasound of uterine adnexa was used to record the intrauterine pregnancy
The pregnancy of the patients was followed up by telephone three months after surgery for at least 1 year, and the clinical pregnancy rate was recorded.
Measured: The pregnancy of the patients was followed up by telephone three months after surgery for at least 1 year, and the clinical pregnancy rate was recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start25 May 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion31 May 2024 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lili Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Yingchun Ma, Doctor, Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003869
- Sponsor's protocol ID
- QCT042806
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data of participants and participants in the study will be kept confidential and will only be used for statistical analysis by the study team
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions
- ClinicalTrials.gov ID
- NCT05003869
- Acronym / sponsor ID
- QCT042806
- Conditions
- Intrauterine Adhesion, Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Lili CaoUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 13 Aug 2021 (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.
TCRA is an important surgical method to restore normal menstrual cycle and improve the outcome of pregnancy.However, postoperative intrauterine adhesion, uterine cavity deformation and difficulty in normal intimal growth seriously affect the efficacy of surgery. A large number of existing studies have shown that even after surgical treatment, women with a history of IUA are still at a reproductive disadvantage.Whether scar tissue plays a role in these influencing factors? At present, there is a variety of surgical methods, and there is no clear guideline consensus on how to deal with intrauterine scar tissue during surgery.
Detailed description
Intrauterine adhesions (IUA) are pathological symptoms of endometrial basal layer damage, fibrous tissue formation and tissue bridge between uterine walls caused by a variety of reasons.In recent years, with the increase of uterine operations such as hysterotomy and cesarean section, the incidence of IUA has been increasing year by year.IUA is mainly manifested by reduced menstrual volume, amenorrhea, recurrent abortion, infertility and abnormal implantation of embryos, etc., which poses a great threat to the health and quality of life of patients.Transcervieal resection of adhesions (TCRA) is a targeted method to separate intrauterine adhesions under direct vision and basically restore the morphology of the intrauterine cavity. It is an important surgical method to improve the pregnancy outcome.However, a large number of existing studies have shown that women with a history of IUA remain at a reproductive disadvantage even after surgical treatment.
Based on the current situation, the investigators have designed this topic, to conduct a study on TCRA intraoperative scar tissue to remove the necessity of clinical and basic research, explore the scar tissue resection or not for the clinical curative effect and the effect of combined tissue morphology, molecular biology research, for TCRA intraoperative how to deal with the scar tissue provide a certain amount of practice and theory basis.
Estrogen receptor (e-r) and progesterone receptor (P - R) is located in the nucleus, when the receptor and hormones to form complexes, again in the form of activation combined into specific areas of the chromosome, gene activation, synthesis of new DNA transcription, and synthesis of new proteins, through the biological function of protein regulating cell growth and metabolism.Specifically, they participate in the reconstruction and regeneration of endometrial blood vessels and cells.The number and functional status of hormone receptors determine the local levels of estrogen and progesterone that can exert biological effects. If the expression of E-R and P-R is reduced or the function is abnormal, the sensitivity and reactivity of endometrium to hormones will be directly reduced, and the endometrial growth will be affected.
The treatment of IUA is mainly based on direct separation of the adhesive tissue, supplemented by the corresponding hormone or cytokine therapy.Among them, estrogen is widely used.On the one hand, it plays a corresponding role by binding with receptors; on the other hand, it affects the fibrinogen and extracellular matrix deposition by regulating the expression of TGF-β or MMP-9, thus participating in the occurrence of intrauterine adhesions.
Studies have found that there is a certain correlation between transforming growth factor-β1 (TGF-β1) and the pathogenesis of IUA. TGF-β1 is a kind of cytokine that is synthesized and secreted by lymphocytes, macrophages, platelets and other cells and can regulate cell growth and differentiation, belonging to the TGF family.It can promote tissue fibrosis and extracellular matrix production, and can increase the amount of fibronectin and collagen.However, a number of studies have confirmed that inhibiting the expression of TGF-β1 or reducing its activity can effectively reduce the degree of fibrosis in liver, kidney and other tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative resection of intrauterine scar tissue by TCRA | Experimental | Procedure: Scar tissue is removedStudy group: patients took the bladder lithotomy position, routinely disinfected vulva and vagina, and laid sterile towel and sheet.pliers Clamp the front lip of the cervix, explore the depth of the uterine cavity, dilate the cervical canal one by one, place the endoscopy, and examine the uterine cavity.After the scar tissue contracted on one side, the scar tissue was disintegrated at the boundary between the intima and scar tissue. The scar tissue was removed with the annular electrode, and a balloon was placed after surgery to prevent re-adhesion.Complete adhesion release is defined as a return to normal shape of the uterine cavity with bilateral uterine angles exposed. |
| No scar tissue resection group | No intervention | –During the operation, the scar tissue covering the anterior, posterior and lateral walls of the uterine cavity was ploughed longitudinally into several narrow strips with needle-like electrodes, and scar tissue was not excised. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Consensus of Chinese Experts on the Clinical Diagnosis and Treatment of Intrauterine Adhesions, i.e., patients with previous history of induced abortion and other intrauterine operations, accompanied by periodical abdominal pain, fewmenorrhea, amenorrhea, recurrent abortion, infertility, and uterine adhesions found by hysteroscopy, who have fertility requirements;
- According to the American Reproductive Society prognostic classification, the AFS score was moderate to severe intrauterine adhesions, that is, the score range was 5-12 points;
- Patients ranged in age from 18 to 42 years old;
- normal endocrine function and ovulation;
- Patients had comprehensive clinical data and were followed up after surgery.
Key exclusion criteria (5 listed)
- Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction and other systemic diseases;
- Patients who recently received female genital surgery or underwent high uterine flexion and were unable to receive hysteroscopy and surgical treatment;
- Amenorrhea, recurrent abortion and infertility caused by other factors such as neuro-endocrine system disorders or congenital abnormalities of reproductive structure and development;
- Patients with allergic reaction to estrogen and other drugs;
- Severe abnormal semen of the spouse.
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 |
|---|---|---|
| Scar tissue is removedAlso: No scar tissue is removedThe patients were divided into two groups according to whether the scar tissue was removed during TCRA operation: study group: resection of uterine scar tissue during TCRA operation;In the control group, the scar tissue covering the anterior, posterior and lateral walls of the uterine cavity was ploughed longitudinally into several narrow strips using needle-like electrodes, and the scar tissue was not excised. | Procedure or surgery | Intraoperative resection of intrauterine scar tissue by TCRA |
Primary outcome
The menstrual chart records changes in menstrual volume
Time frame: 1 to 3 months before surgery and the first month after the operation
Menstrual chart records the amount of menstruation before and after surgery:Menstrual volume is basically normal;Menstrual volume increased compared with preoperative;Still amenorrhea or menstrual volume is not increased
Preoperative and postoperative changes in endometrial thickness were recorded by Doppler ultrasonography.
Time frame: Ultrasound examinations were performed before and 2 weeks after the first operation, and 2 weeks after the second operation
Ultrasound was used to record endometrial thickness before and 2 weeks after the first operation. The second hysteroscopy was performed 3-7 days after the first clean menstruation after the first operation, and ultrasound was performed again 2 weeks after the operation to record the data and compare the endometrial thickness of each group.
Preoperative and postoperative changes of intrauterine adhesions were recorded according to the American Fertility Society score in 1988: mild :1 ~ 4; Moderate: 5-8; Severe: 9-12 points
Time frame: The first operation time is 3-7 days after menstruation (excluding amenorrhea pregnancy can be operated at any time). The second operation was performed 1 month after the first operation
The operation time was within 3-7 days after menstruation (surgery could be performed at any time after excluding pregnancy for amenorrhea). Preoperative hysteroscopy scores and surgical procedures were all performed by the same surgeon.Intrauterine adhesions were measured using the 1988 American Fertility Society (AFS) score. Three to seven days after the first menstrual cleanness, the patient was admitted to the hospital for hysteroscopic reexamination. During hysteroscopy, the intrauterine adhesion and intimal recovery of the patient were explored.
1 secondary outcome
Ultrasound of uterine adnexa was used to record the intrauterine pregnancy
Time frame: The pregnancy of the patients was followed up by telephone three months after surgery for at least 1 year, and the clinical pregnancy rate was recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No. Personal data of participants and participants in the study will be kept confidential and will only be used for statistical analysis by the study team
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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.
Yingchun Ma, Doctor study chair
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scar tissue is removed in people with Intrauterine Adhesion and Scar, run by Lili Cao 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 5 inclusion and 5 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 9 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lili Cao (89269891, qykyc309@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The menstrual chart records changes in menstrual volume (time frame: 1 to 3 months before surgery and the first month after the operation). The study lists 3 primary outcomes in all. 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 9 Sep 2021.