A Multicenter, Prospective, Randomized, Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on the Natural Pregnancy Outcomes in Patients With Non-recurrent Spontaneous Abortion
Phase: NA
Conditions: Infertility and Miscarriage
Sponsor: The Third Xiangya Hospital of Central South University

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Clinical research plan 
 
A multicenter, prospective, 
randomized, controlled clinical study on 
the effect of hysteroscopic uterine 
septum resection on the natural 
pregnancy outcomes in patients with 
non-recurrent spontaneous abortion 
 
Sponsor: The Third Xiangya Hospital of Central South 
University 
 
Lead unit: The Third Xiangya Hospital of Central South 
University 
 
Funding source: Self-raised 
 
Research unit: The Third Xiangya Hospital of Central South 
University 
 
Principal Investigator: Xu Dabao 

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Table of contents 
Clinical Research Plan  ........................................................................................................................................1 
Study Protocol Summary  ................................................................................................................................4 
List of research centers and researchers6 8 
 
 
 

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Study Protocol Summary 
Research title: A multicenter, prospective, randomized, controlled 
clinical study on the effects of hysteroscopic uterine septum 
resection on the natural pregnancy outcomes in patients with non-
recurrent miscarriage 
     
Purpose of the study: 
To compare the effects of hysteroscopic septate resection versus 
expectant management on spontaneous pregnancy outcomes in women with 
septate uterus and non-recurrent miscarriage. 
 
Study Design: 
Multicenter, prospective, randomized, controlled, interventional 
clinical study. 
 
Research process: 
This study was a multicenter randomized controlled trial. 
Patients with uterine septate who planned to try to conceive 
naturally were randomly assigned to a group receiving hysteroscopic 
hysterectomy and a non-surgical treatment group (hysteroscopic 
endometrial polypectomy and other uterine intrauterine surgeries were 
allowed, but septum removal was not performed) in a 1:1 ratio. The 
patients were followed up for at least 12 months after the start of 
pregnancy 
attempts. 
The 
intraoperative 
and 
postoperative 
hysteroscopic review of the surgical group was recorded. The clinical 
pregnancy rate, ongoing pregnancy rate, and live birth rate (follow-
up to delivery) within 12 months after the two groups were followed 
up to evaluate the clinical value of hysteroscopic hysterectomy. At 
the same time, the cumulative miscarriage rate and premature birth 

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rate, health economics indicators, and patient reproductive quality 
of life scores were compared to evaluate the long-term effect of 
surgical treatment. 
 
Inclusion criteria: 
(1) The patient meets the 2024 ASRM diagnostic criteria for uterine 
septate after 3D color Doppler ultrasonography; 
(2) The patient may not have ever been pregnant, or may have a history 
of live birth, one biochemical pregnancy, or one fetal arrest. 
The patient may also be an infertile patient who wishes to 
conceive naturally, such as a patient with laparoscopic ostomy 
for hydrosalpinx, or a patient whose infertility factor can be 
treated. 
(3) Aged between 20-40 years old; 
(4) Plan to try to conceive naturally to achieve your wish of having 
a baby; 
(5) Normal ovarian reserve function (AMH>1.1ng/ml, FSH<12U/L on the 
2nd to 5th day of menstruation); 
(6) The man's semen is generally normal; 
(7) Sign the informed consent form and accept and adhere to treatment 
and follow-up. Patients in the control group can undergo 
hysteroscopy or hystero-laparoscopy to treat other problems, but 
no mediastinectomy. 
 
Exclusion criteria: 
(1) Recurrent miscarriage; 
(2) Patients with uterine intramural fibroids larger than 3 cm and 
moderate to severe intrauterine adhesions; 
(3) Uncontrolled endocrine disorders, such as abnormal thyroid 

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function (FT3, FT4 abnormal), hyperprolactinemia (greater than 2 
times the upper limit of normal), combined with uncontrolled 
endometrial hyperplasia, combined with EIN or malignant lesions, 
acute inflammation of the reproductive system, coagulation 
dysfunction, etc.; if combined with endometrial polyps or 
submucosal myoma, they can still be included in the group after 
resection; 
(4) Patients with combined adenomyosis (uterine body>50 days of 
pregnancy), chocolate cysts>4cm in diameter without treatment, 
or severe dysmenorrhea and clear DIE lesions (diameter>1cm) can 
be palpated in the gynecological triple examination; 
(5) There is untreated bilateral hydrosalpinx or obstruction; 
(6) Other major organ diseases and other surgical contraindications 
or relative contraindications. Other conditions that are not 
suitable for assisted reproductive treatment. Participated in 
other clinical research (within the past three months); 
(7) Those who are assessed to need IVF (for example, those whose 
fallopian tubes cannot be cleared, or whose ovulation dysfunction 
cannot be treated with medication, etc.). 
 
Statistical methods: 
The primary analysis will be conducted according to the 
intention-to-treat principle (ITT), that is, all randomized subjects 
will be statistically analyzed according to the original randomly 
assigned groups; sensitivity analysis will be performed according to 
the actual treatment regimen received by the patients. Categorical 
variables will be described as frequencies and percentages, and the 
chi-square test will be used for inter-group comparisons. Continuous 
variables will be tested for normal distribution. Continuous 

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variables that conform to normal distribution are described as mean 
± standard deviation, and the t test will be used for inter-group 
comparisons; continuous variables that do not conform to normal 
distribution are described by median (25th percentile-75th 
percentile), and the Wilcoxon rank sum test will be used for inter-
group comparisons. For binary outcome indicators, relative risks (RR) 
and corresponding 95% confidence intervals (95% CI) will be 
calculated. SPSS software will be used for statistical analysis. P < 
0.05 is considered statistically significant. Finally, the clinical 
utility index (CUI) was calculated using the live birth rate 
indicator to evaluate the clinical value of TCRS. 
 
 

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List of research centers and researchers 
Institution 
No. 
Principal 
Investigator 
Institution Name 
01 
Xu Dabao 
The Third Xiangya Hospital of 
Central South University 
02 
Congqing 
Obstetrics and Gynecology Hospital 
Affiliated to Fudan University 
03 
Deng Shan 
Peking 
Union 
Medical 
College 
Hospital 
04 
Du Xin 
Hubei Maternal and Child Health 
Hospital 
05 
Feng Limin 
Beijing Tiantan Hospital Affiliated 
to Capital Medical University 
06 
Gao Ting 
Anhui Provincial Hospital 
07 
Huang Xiaowu 
Fuxing 
Hospital 
Affiliated 
to 
Capital Medical University 
08 
Li Qiang 
Tongji 
Hospital 
Affiliated 
to 
Tongji Medical College of Huazhong 
University 
of 
Science 
and 
Technology 
09 
Ma Rui 
Yunnan Provincial First People's 
Hospital 
10 
Huang Xiufeng 
Department 
of 
Obstetrics 
and 
Gynecology, 
Zhejiang 
University 
School of Medicine 
11 
Tang Shuai 
The First Affiliated Hospital of 
Army Medical University 
12 
Wang Lina 
Jilin University First Hospital 
13 
Wang Yingmei 
Tianjin Medical University General 

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Hospital 
14 
Wei Li 
Air Force Medical University Xijing 
Hospital 
15 
Yan Lei 
Reproductive Hospital Affiliated to 
Shandong University 
16 
Zhang Hao 
Guangzhou First People's Hospital 
17 
Zhu Tianyuan 
Gansu Maternal and Child Health 
Hospital 
 
 
 

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Research text 
1. Background 
Septate uterus is the most common type of congenital uterine 
anomaly (CUA) in women , accounting for 35% of such abnormalities. 
Septate uterus is closely related to adverse pregnancy outcomes such 
as recurrent miscarriage, infertility, premature birth, and fetal 
malformation . The degree of impact on pregnancy is affected by factors 
such as the size, thickness, and vascularization level of the septum . 
As one of the malformations with the worst reproductive outcomes, 
uterine septum has attracted much attention in clinical practice 
[ 1] . 
In 1988, the American Fertility Society (AFS) revised the 
classification system for female reproductive organ anomalies 
[ 2] , 
which divides septate uterus into two subtypes: complete (a) and 
partial (b), which are collectively classified as Class V. In 2024, 
the American Society for Reproductive Medicine (ASRM) proposed two 
numerical indicators: a septum length greater than 1 cm and an angle 
formed by the indented endometrium of the uterine fundus septum less 
than 90° can be diagnosed as an incomplete septate uterus 
[ 3] . It was 
particularly pointed out that it is very important to distinguish 
between an arcuate uterus and a septate uterus. The arcuate uterus is 
a normal variation and is not associated with adverse clinical outcomes. 
Only with a clear diagnosis can the population that will benefit from 
surgical intervention be accurately determined. 
There are various diagnostic methods for septate uterus. Although 
two-dimensional ultrasound can only diagnose about 50% of uterine 
malformations, it is usually used as a preliminary screening method 
for uterine malformations due to its low false positive rate . With 
the continuous development of medical imaging technology, three-
dimensional 
ultrasound 
has 
gradually 
replaced 
two-dimensional 

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ultrasound , which can clearly display the contour morphology of the 
uterine fundus and the characteristics of the endometrium, thereby 
achieving a more accurate diagnosis of the type of uterine malformation. 
This technology makes up for the shortcomings of two-dimensional 
ultrasound in diagnostic accuracy , and its sensitivity and specificity 
are almost close to 100% 
[ 4][ 5] . In 2024, the American Society for 
Reproductive Medicine (ASRM) recommended the use of three-dimensional 
transvaginal ultrasound with or without saline infusion as a first-
line non-invasive diagnostic tool for uterine morphology assessment 
(level B evidence). Hysterosalpingography (HSG) can more clearly 
display the internal structure of the uterine cavity by filling the 
uterine cavity with contrast agent . Its diagnostic sensitivity and 
specificity for uterine malformations are 78% and 90%, respectively 
[ 6] . In addition, HSG can be used to evaluate the patency of both 
fallopian tubes, thereby preliminarily screening for tubal-related 
infertility factors. However, this examination cannot evaluate the 
appearance of the uterus, so there are certain difficulties in 
distinguishing a bicornuate uterus . The advantage of hysteroscopy is 
that it can accurately determine the type of septum (complete septum 
or incomplete septum), and simultaneously perform pathological 
examinations and other operations to exclude other intrauterine lesions 
and provide reliable information on related parts such as the vagina 
and cervical canal. However, hysteroscopy cannot evaluate the external 
contour or thickness of the uterine wall, so there are limitations in 
distinguishing between uterine septum and bicornuate uterus. This 
deficiency can be compensated by combined laparoscopy and clarify the 
specific situation of the fallopian tubes. Magnetic resonance imaging 
(MRI): MRI examination can well display the internal structure of the 
uterine cavity and the appearance of the uterus, and has a high accuracy 

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in diagnosing a septate uterus . Its advantages include non-
invasiveness, high resolution of soft tissue, and help in the diagnosis 
of other types or complex uterine malformations 
[ 7] . In summary, in 
order to clarify the diagnosis of uterine septation and clearly 
distinguish it from other uterine malformations, this study used three-
dimensional transvaginal ultrasound as the diagnostic standard and 
adopted the ASRM 2024 septum diagnostic criteria. Specifically, when 
the length of the septum is greater than 1 cm and the angle formed by 
the concave endometrium of the septum at the bottom of the uterus is 
less than 90°, it can be diagnosed as an incomplete uterine septate ; 
if the lower edge of the septum reaches or exceeds the internal cervical 
os, it is diagnosed as a complete uterine septate. For controversial 
cases, a combined hysteroscopy and laparoscopy can be used to confirm 
the diagnosis. 
In recent years, hysteroscopic transcervical resection of septa 
(TCRS) has been increasingly used in clinical practice and has become 
the standard procedure for correcting uterine septum. In order to 
reduce the occurrence of postoperative intrauterine adhesions, a 
variety of intervention measures are often taken in clinical practice , 
including estrogen therapy, intrauterine balloon or contraceptive 
device placement, and intrauterine injection of sodium hyaluronate gel. 
However, studies have shown that there is no significant difference in 
the effect of different postoperative intervention measures in reducing 
the incidence of postoperative intrauterine adhesions 
[ 8] . This study 
uniformly adopted the postoperative placement of a 12Fr Foley balloon 
and the injection of cross-linked sodium hyaluronate gel to prevent 
adhesions in order to simplify some data collection and analysis 
processes, and a disposable intrauterine stent was placed when 
necessary. 

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using a variety of methods, including hysteroscopic cold knife 
incision, monopolar or bipolar electrode incision, and laser incision . 
The duration of hysteroscopic surgery , the thickness and distribution 
of residual endometrium after surgery , and the number of surgeries 
have an important impact on postoperative prognosis . In the clinical 
treatment of uterine septate, clinicians need to comprehensively 
consider their own technical proficiency , hospital equipment 
conditions, and the specific conditions of the patient to select the 
most appropriate surgical method. In the specific surgical operation, 
careful operation should be performed to avoid complications such as 
uterine perforation , and the endometrium should be protected as much 
as possible . The normal morphology of the uterine cavity should be 
restored as much as possible in the first operation . In the case of 
bilateral uterine wall cohesion, full incision should be performed if 
necessary. Intervention measures should also be taken after surgery to 
reduce the occurrence of intrauterine adhesions, so as to achieve the 
best surgical effect of treating uterine septate 
[ 9] .  
the existing observational studies and non- randomized controlled 
studies on the effect of hysteroscopic septate resection on the outcome 
of natural pregnancy attempts in patients with uterine septate , there 
is still controversy about whether TCRS should be routinely performed 
before natural pregnancy attempts . The 2024 American Society of 
Reproductive Medicine (ASRM) guidelines for uterine septate pointed 
out that patients with infertility and/or undergoing fertility 
treatment should be informed that septate resection may not necessarily 
increase the live birth rate. Given the limitations of the existing 
literature and the low risk of surgery, septate resection can be 
offered to patients under shared decision-making (level B evidence). 
At the same time, the guidelines recommend that hysteroscopic septate 

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resection be offered to patients with septate who have a history of 
recurrent miscarriage under a shared decision-making model (evidence 
strength: B; recommendation strength: moderate). 
However, there are many problems with current randomized controlled 
studies , including small sample size, unstable indicators, and low 
test power. In addition, these studies did not describe the random 
allocation and concealed allocation scheme , nor did they clarify 
whether the blind method was used to evaluate the efficacy, so there 
may be a risk of selective bias. In addition, the specific surgical 
method of hysteroscopic hysterectomy used in the study is unclear, the 
surgical instruments and the proficiency of the operator are uncertain, 
and the inclusion criteria of the study are not unified, resulting in 
a low level of research evidence . Therefore, it is urgent to carry 
out high-quality, large-sample prospective randomized controlled 
multicenter clinical trials, using a fully randomized design , unified 
inclusion and exclusion criteria and treatment plans, in order to 
obtain more powerful evidence, so as to guide the clinical treatment 
of patients with uterine septate who plan to try to conceive naturally , 
improve the uterine cavity environment, improve their fertility and 
improve pregnancy outcomes. 
To this end, this research group intends to conduct a multicenter, 
prospective, randomized controlled clinical study, mainly including 
patients with uterine septate who plan to try to conceive naturally . 
The study will divide the subjects into two groups: one group undergoes 
hysteroscopic hysterectomy (surgical group), and the other group only 
receives routine pre-pregnancy counseling and observation (non-TCRS 
group, control group). In addition, the study will also include 
infertile patients who use hysteroscopy and laparoscopy as a treatment 
method and aim to try to conceive naturally. By comparing the live 

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birth rate, pregnancy rate, and premature birth rate of the two groups , 
we will provide evidence-based medical evidence for the choice of 
treatment methods for patients with uterine septate who plan to try to 
conceive naturally , and evaluate the impact of TCRS on the outcome of 
postoperative natural pregnancy attempts and its clinical application 
value. 
 
2. Purpose 
Compare the effects of hysteroscopic uterine septate resection 
and non- surgical (conservative observation) on the natural pregnancy 
outcomes of patients with uterine septate and non-recurrent 
miscarriage, and also cover the treatment of other infertility 
factors for infertile patients with the purpose of natural conception 
(such as laparoscopic treatment of fallopian tube factors or 
hysteroscopic fallopian tube catheterization, etc.). This study will 
provide evidence-based medical evidence for the treatment of patients 
with uterine septate who want to have children, thereby guiding 
clinical decision-making. 
 
3. Study Design 
3.1 Sample size calculation 
The primary outcome measure of this study was live birth rate. 
According to the results of retrospective clinical data analysis, the 
clinical pregnancy rate in the surgical group was 50%, and the 
clinical pregnancy rate in women with uterine septate who did not 
undergo surgery was 35%. Using a two-sided test, the α error was set 
to 5%, the β error was set to 20%, and the total minimum sample size 
was calculated using the PASS sample size calculation software to be 

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167 cases. Considering the withdrawal rate of about 20%, the final 
sample size was adjusted to 418 , and 209 women were planned to be 
included in each group. 
 
3.2 Flowchart 
 
 
4. Research content 
4.1 Research period 
April 2025 to March 2028 
4.2 Number of patients enrolled 
Total number of cases: 418, 50 in our center 

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4.3 Selection criteria 
(1) The patient meets the 2024 ASRM diagnostic criteria for uterine 
septate after 3D color Doppler ultrasonography; 
(2) The patient may not have ever been pregnant, or may have a history 
of live birth, one biochemical pregnancy, or one fetal arrest. The 
patient may also be an infertile patient who wishes to conceive 
naturally, such as a patient with laparoscopic ostomy for 
hydrosalpinx, or a patient whose infertility factor can be treated. 
(3) Aged between 20-40 years old; 
(4) Plan to try to conceive naturally to achieve your wish of having a 
baby; 
(5) Normal ovarian reserve function (AMH>1.1ng/ml, FSH<12U/L on the 2nd 
to 5th day of menstruation); 
(6) The man's semen is generally normal; 
(7) Sign the informed consent form and accept and adhere to treatment 
and follow-up. Patients in the control group can undergo 
hysteroscopy or hystero-laparoscopy to treat other problems, but 
no mediastinectomy. 
4.4Exclusion criteria 
(1) Recurrent miscarriage; 
(2) Patients with uterine intramural fibroids larger than 3 cm and 
moderate to severe intrauterine adhesions; 
(3) Uncontrolled endocrine disorders, such as abnormal thyroid function 
(FT3, FT4 abnormal), hyperprolactinemia (greater than 2 times the 
upper limit of normal), combined with uncontrolled endometrial 
hyperplasia, combined with EIN or malignant lesions, acute 
inflammation of the reproductive system, coagulation dysfunction, 
etc.; if combined with endometrial polyps or submucosal myoma, they 

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can still be included in the group after resection; 
(4) Patients with combined adenomyosis (uterine body>50 days of 
pregnancy), chocolate cysts>4cm in diameter without treatment, or 
severe dysmenorrhea and clear DIE lesions (diameter>1cm) can be 
palpated in the gynecological triple examination; 
(5) There is untreated bilateral hydrosalpinx or obstruction; 
(6) Other major organ diseases and other surgical contraindications or 
relative contraindications. Other conditions that are not suitable 
for assisted reproductive treatment. Participated in other clinical 
research (within the past three months); 
(7) Those who are assessed to need IVF (for example, those whose 
fallopian tubes cannot be cleared, or whose ovulation dysfunction 
cannot be treated with medication, etc.). 
4.5 Research steps  
（1）who visited the outpatient clinic , planned to achieve 
pregnancy through natural conception , and met the diagnostic criteria 
for uterine septate were selected. The researchers received the 
patients and had a detailed conversation with them. If the patients 
agreed to participate in the study, after signing the relevant informed 
consent form, the patients' medical history, menstrual history, 
pregnancy and childbearing history, and other information were 
collected, and the quality of life assessment scale was filled out . 
All patients underwent three-dimensional ultrasound examination on the 
16th to 24th day of menstruation to further clarify the diagnosis and 
conduct an initial assessment of the length, range, nature, and degree 
of uterine septate (generating a three-dimensional ultrasound 
structured report). After completing the inclusion criteria assessment, 
the patients were randomly divided into two groups at a 1:1 ratio using 

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a random number table : 
Surgical group: patients received surgical treatment for uterine 
septum, during which possible endometrial polyps, mild intrauterine 
adhesions, and submucosal myomas could be treated simultaneously. There 
was no limit on the anesthesia method, and hysteroscopy followed the 
hysteroscopic operation strategy of "no exploration of the uterus, no 
dilation of the uterus". Hysteroscopic surgery is divided into two 
categories: one is plasma hysteroscopic resection (actually TCIS), 
which uniformly uses a 7mm external diameter hysteroscopic resectoscope 
to reduce the difficulty of cervical dilation; the other is micro (5 
or 7Fr) hysteroscopic cold knife incision, equipped with a 5Fr bipolar 
electrocoagulation stick for electrocoagulation and hemostasis. When 
cutting the septum, the principle of protecting the endometrium should 
be followed. If the left and right side walls are obviously convex, 
correction can be performed at the same time and detailed records 
should be recorded. In order to prevent rupture of the uterine fundus 
in late pregnancy, it is necessary to ensure that the uterine fundus 
muscle layer retains at least 10mm thickness (combined with 
preoperative three-dimensional color ultrasound and intraoperative 
monitoring ultrasound judgment). 
16 to 24 days after the first menstruation after the operation, 
recheck 
with 
three-dimensional 
ultrasound, 
and 
recheck 
with 
hysteroscopy after the second menstruation to observe the uterine 
cavity. If there is any residual septum, it should be treated and 
recorded. After the hysteroscopy recheck confirms that there are no 
contraindications, you can actively try to get pregnant after the first 
menstruation. 
Control group: routine pre-pregnancy counseling and observation 
without TCRS treatment, active pregnancy attempts . If combined with 

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other hysteroscopic indications, hysteroscopy was performed within 3-
7 days after menstruation ended, and possible endometrial polyps, 
intrauterine adhesions (mild), submucosal myomas and other lesions were 
treated during the operation, and uterine septum was not treated. 
The cervical septum was not treated in both groups. After TCRS, a 
12Fr Foley balloon was uniformly placed ( 3 ml of saline was injected 
into the balloon and placed for 5 days) and cross-linked sodium 
hyaluronate gel was injected into the uterine cavity to prevent the 
formation of intrauterine adhesions. A disposable intrauterine stent 
was placed when necessary, such as when the bilateral uterine walls 
were treated during the operation, mild intrauterine adhesions were 
combined, and the uterine cavity was small (the distance between the 
bilateral uterine angles was less than 35 mm). A follow-up of 12 months 
was performed after the operation or treatment course, and the 
reproductive outcomes of pregnancy within 12 months after the pregnancy 
attempt were recorded . 
(2) Follow-up phase 
The two groups of patients were followed up for 12 months or more 
from the time they decided to try to conceive to track their 
reproductive outcomes. If the patient successfully became pregnant, 
they would enter the pregnancy follow-up stage and continue to be 
followed up until postpartum. If the patient was lost to follow-up 
(defined as lost to follow-up if they could not be contacted for two 
consecutive follow-ups) or voluntarily withdrew from the study, the 
follow-up would be terminated. 
Pregnancy follow-up 
First pregnancy follow-up: After menopause , measure blood hCG. 
Second pregnancy follow-up: around 8 weeks of pregnancy, obtain 
relevant indicators of early pregnancy ultrasound examination. 

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The third pregnancy follow-up: around 28 weeks of pregnancy. Mainly 
to obtain information on fetal development, placental status and 
pregnancy complications during pregnancy. 
Fourth pregnancy follow-up: 6 weeks after delivery, through 
telephone interviews or on-site visits, combined with the patient's 
prenatal examination records, photocopied obstetric medical records or 
login to the postpartum information registration system, and neonatal 
medical records, the following information was collected: ① Detailed 
information on pregnancy complications in the late pregnancy (e.g., 
hypertensive disorders complicating pregnancy, gestational diabetes, 
placental abruption, placenta accreta, placenta previa, intrauterine 
growth restriction, cervical insufficiency, premature rupture of 
membranes, premature birth, stillbirth, amniotic fluid abnormalities, 
etc.); ② Extracting delivery-related information (e.g., gestational 
age, mode of delivery, stillbirth, placental, umbilical cord or 
amniotic fluid abnormalities, fetal distress, delivery complications, 
etc.); ③ Neonatal-related information (gender, birth weight, Apgar 
score, birth defects, etc.); ④ Detailed information on postpartum 
complications (e.g., postpartum depression, puerperal infection and/or 
late postpartum hemorrhage) and neonatal complications (e.g., neonatal 
respiratory distress syndrome, neonatal jaundice, neonatal infection, 
neonatal death and/or neonatal hospitalization); inquire and record 
concomitant medications and adverse events. 
Pregnancy follow-up should focus on obstetric intervention 
measures during pregnancy, such as pregnancy preservation treatment, 
and record the use of concomitant medications in detail. If the 
pregnancy is terminated, the cause of termination, gestational age and 
other related information should be clearly recorded . 
This study does not involve sample collection. 

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5. Evaluation indicators  
5.1 Main evaluation indicators 
Live birth rate within 12 months after the start of pregnancy 
attempt in both groups . 
5.2 Secondary evaluation indicators 
（1）within 1 to 2 months of starting to try to conceive, the 
miscarriage rate, the premature birth rate , as well as the obstetric 
complications, 
neonatal 
outcomes, 
cost-effectiveness, 
and 
the 
occurrence of other adverse events . 
The changes in endometrial thickness before and after mediastinectomy, 
the changes in quality of life scores of patients before and after 
surgery , the time interval from surgery to pregnancy, and the 
incidence of surgical complications were analyzed in the surgical group. 
 
6. Security considerations 
（1）Risk of wound adhesion after uterine septum surgery: Place a 
12Fr Foley balloon (5 days) and inject cross-linked sodium 
hyaluronate gel after surgery to prevent the formation of 
intrauterine adhesions. If necessary, place a disposable intrauterine 
stent. If the bilateral walls of the uterine cavity are treated 
during surgery, mild intrauterine adhesions occur, and the uterine 
cavity is small (the distance between the bilateral uterine angles is 
less than 35mm). Closely observe changes in menstrual volume after 
surgery, regularly evaluate whether adhesions are formed through 
three-dimensional ultrasound, and take surgical treatment of 
intrauterine adhesions if necessary. 

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（2）Risk of bleeding after TCRS surgery and risk of electrothermal 
injury: Uterine contraction and hemostatic drugs are available during 
surgery to reduce the risk of bleeding, uterine distension pressure 
is reduced during surgery, the presence of bleeding points is fully 
assessed, and complete hemostasis is ensured. At the same time, the 
frequency of electrosurgery is reduced as much as possible during 
surgery, and the power of the electrosurgery is appropriately reduced 
to avoid electrothermal injury. 
（3）Other risks of hysteroscopic surgery, such as water 
intoxication, infection, etc.: Strictly follow the operating 
specifications, control the operation time, minimize the uterine 
distension pressure, and ensure complete hemostasis to reduce the 
occurrence of surgery-related complications. 
（4）Other unforeseen risks. 
 
7. Statistical analysis 
The primary analysis will be conducted according to the intention-
to-treat principle (ITT), that is, all randomized subjects will be 
statistically analyzed according to the original randomly assigned 
groups; sensitivity analysis will be performed according to the actual 
treatment regimen received by the patients. Categorical variables will 
be described as frequencies and percentages, and the chi-square test 
will be used for inter-group comparisons. Continuous variables will be 
tested for normal distribution . Continuous variables that conform to 
normal distribution are described as mean ± standard deviation, and 
the t test will be used for inter-group comparisons; continuous 
variables that do not conform to normal distribution are described by 
median (25th percentile-75th percentile), and the Wilcoxon rank sum 
test will be used for inter-group comparisons. For binary outcome 

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indicators, relative risks (RR) and corresponding 95% confidence 
intervals (95% CI) will be calculated. SPSS software will be used for 
statistical analysis. P < 0.05 is considered statistically significant. 
Finally, the clinical utility index (CUI) was calculated using the live 
birth rate indicator to evaluate the clinical value of TCRS. 
 
8. Quality Management 
Researchers should ensure that the data are authentic, accurate, 
complete and traceable, and should ensure the integrity of basic 
clinical research documents during the retention period to avoid 
intentional or unintentional changes or losses. 
 
 
9. Description of the publication format of research results 
This project is a multi-center clinical study. The project will 
follow the principles of equality, mutual benefit, honesty and 
trustworthiness, and the sub-centers and the lead unit will jointly 
carry out the research. 
The ownership of the original medical records and data involved in 
the research process (including but not limited to clinical medical 
records, follow-up materials) and the collected clinical data 
(including but not limited to data collection forms, biological samples) 
are jointly owned by the team leader unit and the sub-center, but are 
limited to use in this study and not for other extended studies. 
The new intellectual property rights generated by this cooperation, 
unless otherwise agreed, shall be jointly owned by the group leader 
and the sub-center. As the initiator of this project, the researcher 
has the right to publish the relevant content of this project for the 
purpose of academic research and promises not to use the project data 
and information for commercial activities. 
 

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10. Ethical Statement 
Clinical research will follow the World Medical Association's 
Declaration of Helsinki, Ethical Review Methods for Biomedical Research 
Involving Humans, Ethical Review Methods for Life Science and Medical 
Research Involving Humans, and Management Methods for Clinical Research 
Initiated by Investigators in Medical and Health Institutions. Before 
the start of the study, the clinical research will be implemented only 
after the research plan is approved by the ethics committee. The 
personal privacy and data confidentiality of the subjects will be 
protected during the research process. I promise to abide by the 
relevant regulations on scientific research norms and integrity. 
 
11. References 
 
【1】 
Akhtar M,Saravelos S,Li T,et al.Reproductive Implications and Management 
of Congenital Uterine Anomalies:Scientific Impact Paper No.62 November 
2019[J].BJOG,2020,127(5):e1-e13. 
【2】 
The American Fertility Society classifications of adnexal adhesions, distal 
tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, 
mullerian anomalies and intrauterine adhesions[J]. Fertil Steril, 1988,49(6):944-
955. 
【3】 
Evidence-based 
diagnosis 
and 
treatment 
for 
uterine 
septum: 
a 
guideline.[J].Fertility and sterility,2024,122(2):251-265. 
【4】 
Vercellini P, De Giorgi O, Cortesi I, et al. Metroplasty for the complete 
septate uterus: does cervical sparing matter?[J]. J Am Assoc Gynecol Laparosc, 
1996,3(4):509-514. 
【5】 
Saravelos S H, Cocksedge K A, Li T C. Prevalence and diagnosis of 
congenital uterine anomalies in women with reproductive failure: a critical 
appraisal[J]. Hum Reprod Update, 2008,14(5):415-429. 
【6】 
Saravelos S H, Cocksedge K A, Li T C. Prevalence and diagnosis of congenital 
uterine anomalies in women with reproductive failure: a critical appraisal[J]. Hum 
Reprod Update, 2008,14(5):415-429. 
【7】 
Economy K E, Barnewolt C, Laufer M R. A comparison of MRI and 
laparoscopy in detecting pelvic structures in cases of vaginal agenesis[J]. J 
Pediatr Adolesc Gynecol, 2002,15(2):101-104.  
【8】 
Yu X,Yuhan L,Dongmei S,et al.The incidence of post-operative adhesion 
following transection of uterine septum:a cohort study comparing three different 
adjuvant therapies[J].Eur J Obstet Gynecol Reprod Biol,2016,201:61-64. 

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【9】 Zhang Baiyu, Wu Susu, Zhao Xingping, et al. Treatment of uterine septate[J]. 
Journal of Central South University (Medical Sciences), 2022, 47(11): 1487-
1494.