NCT07611656 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
| NCT ID | NCT07611656 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Third Xiangya Hospital of Central South University |
| Condition | Infertility and Miscarriage |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 236 participants in total. It began in 2025-06-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * (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. Exclusion Criteria: * (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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07611656 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying Infertility and Miscarriage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07611656 currently recruiting?
Yes, NCT07611656 is actively recruiting participants. Contact the research team at forxudabao@126.com for enrollment information.
Where is the NCT07611656 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT07611656 clinical trial?
NCT07611656 is sponsored by The Third Xiangya Hospital of Central South University. The trial plans to enroll 236 participants.