Infertility and MiscarriageNCT07611656
A Multicenter, Prospective, Randomized Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on IVF-ET Outcomes in Infertile Patients With Non-recurrent Miscarriage
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
This study aims to evaluate the impact of hysteroscopic transcervical resection of the septum (TCRS) on fertility in infertile women without recurrent miscarriage, primarily assessing its effect on subsequent IVF-ET outcomes. 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
- 236 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) Meet the 2024 ASRM diagnostic criteria for uterine septate after 3D color Doppler ultrasound examination; (2) Aged between 20 and 40 years old; (3) Meet the diagnosis of infertility: those who have had regular sexual intercourse for at least 12 months but have not achieved clinical pregnancy; (4) Plan to undergo IVF/ICSI (non-PGD); (5) Sign the informed consent form and be able to accept and adhere to treatment and follow-up.
Who cannot join
- (1) Recurrent miscarriage; (2) Combined with untreated intramural uterine fibroids larger than 3 cm, intrauterine adhesions with an AFS score of ≥5 points; (3) Uncontrolled endocrine disorders, such as abnormal thyroid function (FT3, FT4 abnormal), hyperprolactinemia (greater than 2 times the upper limit of normal), combined with atypical endometrial hyperplasia or malignant lesions, acute inflammation of the reproductive system, coagulation dysfunction, etc.; if combined with endometrial polyps or submucosal fibroids, they can still be included in the group after resection; (4) Combined 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 by gynecological triple examination; (5) Untreated severe hydrosalpinx (diameter>3 cm) or hydrosalpinx with reflux confirmed by ultrasound; (6) Other important organ diseases and other surgical contraindications or relative contraindications; other conditions that are not suitable for assisted reproductive treatment; (7) Have participated in other interventional clinical studies (within the last three months).
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, 13017386201, forxudabao@126.com
About this study
This study aims to evaluate the impact of hysteroscopic transcervical resection of the septum (TCRS) on fertility in infertile women without recurrent miscarriage, primarily assessing its effect on subsequent IVF-ET outcomes. The research attempts to answer: for infertile women with uterine septum planning to undergo IVF/ICSI (excluding preimplantation genetic diagnosis), does TCRS improve pregnancy outcomes (such as live birth rate, pregnancy rate, miscarriage rate, etc.) compared to non-surgical treatment (conservative observation), and to clarify the clinical value and safety of this surgical intervention.
- Conditions
- Infertility and Miscarriage
- Being tested
- Transcervical resection of septum
- Keywords
- transcervical resection of septum, In Vitro Fertilization and Embryo Transfer
- 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
Hysteroscopic surgery 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 hysteroscopic septectomy 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 posted28 May 2026
- Study start1 Jun 2025
- Primary completion31 Dec 2027 (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
- 236 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, Anhui Provincial Hospital, Maternal and Child Health Hospital of Hubei Province, The First People's Hospital of Yunnan, Tianjin Medical University General Hospital, Guangzhou First People's Hospital, Gansu Maternal and Child Health Hospital, Shandong University, Women's Hospital School Of Medicine Zhejiang University, The First Hospital of Jilin University, Beijing Tiantan Hospital, Tongji Hospital, Xijing Hospital, Southwest Hospital, China, Fu Xing Hospital, Capital Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611656
- Sponsor's protocol ID
- xy3-TCRS-IVF
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 28 May 2026
- 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 28 May 2026. 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 IVF-ET Outcomes in Infertile Patients With Non-recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT07611656
- Acronym / sponsor ID
- xy3-TCRS-IVF
- Conditions
- Infertility and Miscarriage
- Keywords
- transcervical resection of septum, In Vitro Fertilization and Embryo Transfer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 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, Anhui Provincial Hospital, Maternal and Child Health Hospital of Hubei Province, The First People's Hospital of Yunnan, Tianjin Medical University General Hospital, Guangzhou First People's Hospital, Gansu Maternal and Child Health Hospital, Shandong University, Women's Hospital School Of Medicine Zhejiang University, The First Hospital of Jilin University, Beijing Tiantan Hospital, Tongji Hospital, Xijing Hospital, Southwest Hospital, China, Fu Xing Hospital, Capital Medical University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 28 May 2026 (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.
This study aims to evaluate the impact of hysteroscopic transcervical resection of the septum (TCRS) on fertility in infertile women without recurrent miscarriage, primarily assessing its effect on subsequent IVF-ET outcomes. The research attempts to answer: for infertile women with uterine septum planning to undergo IVF/ICSI (excluding preimplantation genetic diagnosis), does TCRS improve pregnancy outcomes (such as live birth rate, pregnancy rate, miscarriage rate, etc.) compared to non-surgical treatment (conservative observation), and to clarify the clinical value and safety of this surgical intervention.
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 hysteroscopic septectomy |
| 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) Meet the 2024 ASRM diagnostic criteria for uterine septate after 3D color Doppler ultrasound examination; (2) Aged between 20 and 40 years old; (3) Meet the diagnosis of infertility: those who have had regular sexual intercourse for at least 12 months but have not achieved clinical pregnancy; (4) Plan to undergo IVF/ICSI (non-PGD); (5) Sign the informed consent form and be able to accept and adhere to treatment and follow-up.
Key exclusion criteria (1 listed)
- (1) Recurrent miscarriage; (2) Combined with untreated intramural uterine fibroids larger than 3 cm, intrauterine adhesions with an AFS score of ≥5 points; (3) Uncontrolled endocrine disorders, such as abnormal thyroid function (FT3, FT4 abnormal), hyperprolactinemia (greater than 2 times the upper limit of normal), combined with atypical endometrial hyperplasia or malignant lesions, acute inflammation of the reproductive system, coagulation dysfunction, etc.; if combined with endometrial polyps or submucosal fibroids, they can still be included in the group after resection; (4) Combined 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 by gynecological triple examination; (5) Untreated severe hydrosalpinx (diameter>3 cm) or hydrosalpinx with reflux confirmed by ultrasound; (6) Other important organ diseases and other surgical contraindications or relative contraindications; other conditions that are not suitable for assisted reproductive treatment; (7) Have participated in other interventional clinical studies (within the last three months).
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 septumHysteroscopic surgery 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 28 May 2026.
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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 28 May 2026. 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 28 May 2026.