Clinical trial NCT05003869: Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions
Official title: Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesion
Scar
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. 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;
3. Patients ranged in age from 18 to 42 years old;
4. normal endocrine function and ovulation;
5. Patients had comprehensive clinical data and were followed up after surgery.

Exclusion Criteria:

1. Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction and other systemic diseases;
2. Patients who recently received female genital surgery or underwent high uterine flexion and were unable to receive hysteroscopy and surgical treatment;
3. Amenorrhea, recurrent abortion and infertility caused by other factors such as neuro-endocrine system disorders or congenital abnormalities of reproductive structure and development;
4. Patients with allergic reaction to estrogen and other drugs;
5. Severe abnormal semen of the spouse.

Primary outcomes:
measure: The menstrual chart records changes in menstrual volume
timeFrame: 1 to 3 months before surgery and the first month after the operation
measure: Preoperative and postoperative changes in endometrial thickness were recorded by Doppler ultrasonography.
timeFrame: Ultrasound examinations were performed before and 2 weeks after the first operation, and 2 weeks after the second operation
measure: 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
timeFrame: 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:
measure: Ultrasound of uterine adnexa was used to record the intrauterine pregnancy
timeFrame: 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.
Other outcomes:
Locations:
city: Jinan
country: China
facility: China, Shandong Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Yingchun Ma, Doctor
role: STUDY_CHAIR
References: