Infertility and MiscarriageNCT07039097
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
A study testing Transcervical resection of septum in people with Infertility and Miscarriage, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The study aims to compare the effects of transcervical resection of septa (TCRS) and expectant management on the natural pregnancy outcomes of patients with septate uterus without recurrent abortion, also covering the treatment of other infertility factors in infertile patients who aim at natural conception. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility and Miscarriage
- What is being tested?
- Transcervical resection of septum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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) The patient meets the 2024 ASRM diagnostic criteria for uterine septate after three-dimensional color Doppler ultrasound examination; (2) The patient may have never 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 hydrosalpinx and laparoscopic stoma, or a patient whose infertility factors can be treated; (3) The patient is between 20 and 40 years old; (4) The patient plans to try to conceive naturally to achieve the desire to have a baby; (5) The patient has normal ovarian reserve function (AMH>1.1ng/ml, FSH<12U/L on the 2nd to 5th day of menstruation); (6) The male's semen is generally normal; (7) The patient signs the informed consent form and is able to accept and adhere to treatment and follow-up. Patients in the control group can undergo hysteroscopy or hystero-laparoscopy to treat other problems, but septal resection is not performed.
Who cannot join
- (1) Recurrent miscarriage; (2) Patients with intramural uterine myoma larger than 3 cm, 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), uncontrolled endometrial hyperplasia, EIN or malignant lesions, acute inflammation of the reproductive system, coagulation dysfunction, etc.; if combined with endometrial polyps or submucosal myoma, patients can still be included in the group after resection; (4) Patients with adenomyosis (uterine body>50 days of pregnancy), chocolate cysts with a diameter of>4 cm, or severe dysmenorrhea and clear DIE lesions (diameter>1 cm) can be palpated during gynecological triple examination; (5) Untreated bilateral hydrosalpinx or obstruction; (6) Other important organ diseases and other surgical contraindications or relative contraindications. Other situations that are not suitable for assisted reproductive treatment. Those who have participated in other clinical research (within the past three months); (7) Those who are assessed to need IVF (e.g., those whose fallopian tubes cannot be cleared, or whose ovulation dysfunction cannot be treated with medication, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Dabao Xu, 13327215012, forxudabao@126.com
About this study
The study aims to compare the effects of transcervical resection of septa (TCRS) and expectant management on the natural pregnancy outcomes of patients with septate uterus without recurrent abortion, also covering the treatment of other infertility factors in infertile patients who aim at natural conception. The research attempts to answer whether TCRS can improve the live birth rate, pregnancy rate and pregnancy outcomes for septate uterus patients planning natural pregnancy, so as to provide evidence-based medical evidence for the selection of clinical treatment methods for such patients.
- Conditions
- Infertility and Miscarriage
- Being tested
- Transcervical resection of septum
- Keywords
- transcervical resection of septum, Natural Pregnancy
- Medical subject headings
- Infertility, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical resection of septumProcedure or surgery
Transcervical resection of septum (TCRS) is divided into two categories: one is plasma hysteroscopic electrosurgical resection (actually TCIS), which uniformly uses a 7mm external diameter hysteroscopic electrosurgical 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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Experimental | Undergoing Transcervical resection of septum Receives: Procedure: Transcervical resection of septum |
| Control group | No intervention | Routine preconception counseling and observation without hysteroscopic septectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Follow-up was conducted for 12 months after the surgery or treatment course to record the IVF/ICSI reproductive outcomes within 12 months after the initiation of embryo transfer into the cycle.
Measured: within 12 months after initiating embryo transfer
Secondary outcomes (1)
Adverse outcome rate
Pregnancy rate and cumulative pregnancy rate, miscarriage rate and cumulative miscarriage rate, preterm birth rate.
Measured: within 12 months after initiating embryo transfer in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility and MiscarriageStudies 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
- None (open label)
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University, Peking Union Medical College Hospital, Maternal and Child Health Hospital of Hubei Province, Beijing Tiantan Hospital, Anhui Provincial Hospital, Fu Xing Hospital, Capital Medical University, Tongji Hospital, The First People's Hospital of Yunnan, Women's Hospital School Of Medicine Zhejiang University, Southwest Hospital, China, The First Hospital of Jilin University, Tianjin Medical University General Hospital, Xijing Hospital, Shandong University, Guangzhou First People's Hospital, Gansu Provincial Maternal and Child Health Care Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039097
- Sponsor's protocol ID
- xy3-TCRS-NP
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07039097
- Acronym / sponsor ID
- xy3-TCRS-NP
- Conditions
- Infertility and Miscarriage
- Keywords
- transcervical resection of septum, Natural Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University, Peking Union Medical College Hospital, Maternal and Child Health Hospital of Hubei Province, Beijing Tiantan Hospital, Anhui Provincial Hospital, Fu Xing Hospital, Capital Medical University, Tongji Hospital, The First People's Hospital of Yunnan, Women's Hospital School Of Medicine Zhejiang University, Southwest Hospital, China, The First Hospital of Jilin University, Tianjin Medical University General Hospital, Xijing Hospital, Shandong University, Guangzhou First People's Hospital, Gansu Provincial Maternal and Child Health Care Hospital
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 26 Jun 2025 (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.
The study aims to compare the effects of transcervical resection of septa (TCRS) and expectant management on the natural pregnancy outcomes of patients with septate uterus without recurrent abortion, also covering the treatment of other infertility factors in infertile patients who aim at natural conception. The research attempts to answer whether TCRS can improve the live birth rate, pregnancy rate and pregnancy outcomes for septate uterus patients planning natural pregnancy, so as to provide evidence-based medical evidence for the selection of clinical treatment methods for such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: Transcervical resection of septumUndergoing Transcervical resection of septum |
| Control group | No intervention | –Routine preconception counseling and observation without hysteroscopic septectomy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) The patient meets the 2024 ASRM diagnostic criteria for uterine septate after three-dimensional color Doppler ultrasound examination; (2) The patient may have never 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 hydrosalpinx and laparoscopic stoma, or a patient whose infertility factors can be treated; (3) The patient is between 20 and 40 years old; (4) The patient plans to try to conceive naturally to achieve the desire to have a baby; (5) The patient has normal ovarian reserve function (AMH>1.1ng/ml, FSH<12U/L on the 2nd to 5th day of menstruation); (6) The male's semen is generally normal; (7) The patient signs the informed consent form and is able to accept and adhere to treatment and follow-up. Patients in the control group can undergo hysteroscopy or hystero-laparoscopy to treat other problems, but septal resection is not performed.
Key exclusion criteria (1 listed)
- (1) Recurrent miscarriage; (2) Patients with intramural uterine myoma larger than 3 cm, 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), uncontrolled endometrial hyperplasia, EIN or malignant lesions, acute inflammation of the reproductive system, coagulation dysfunction, etc.; if combined with endometrial polyps or submucosal myoma, patients can still be included in the group after resection; (4) Patients with adenomyosis (uterine body>50 days of pregnancy), chocolate cysts with a diameter of>4 cm, or severe dysmenorrhea and clear DIE lesions (diameter>1 cm) can be palpated during gynecological triple examination; (5) Untreated bilateral hydrosalpinx or obstruction; (6) Other important organ diseases and other surgical contraindications or relative contraindications. Other situations that are not suitable for assisted reproductive treatment. Those who have participated in other clinical research (within the past three months); (7) Those who are assessed to need IVF (e.g., those whose fallopian tubes cannot be cleared, or whose ovulation dysfunction cannot be treated with medication, etc.).
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 |
|---|---|---|
| Transcervical resection of septumTranscervical resection of septum (TCRS) is divided into two categories: one is plasma hysteroscopic electrosurgical resection (actually TCIS), which uniformly uses a 7mm external diameter hysteroscopic electrosurgical 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. | Procedure or surgery | Surgical group |
Primary outcome
live birth rate
Time frame: within 12 months after initiating embryo transfer
Follow-up was conducted for 12 months after the surgery or treatment course to record the IVF/ICSI reproductive outcomes within 12 months after the initiation of embryo transfer into the cycle.
1 secondary outcome
Adverse outcome rate
Time frame: within 12 months after initiating embryo transfer in both groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcervical resection of septum in people with Infertility and Miscarriage, run by The Third Xiangya Hospital of Central South University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dabao Xu (13017386201, forxudabao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: within 12 months after initiating embryo transfer). 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 26 Jun 2025.