RecruitingNot Applicable

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

China418 participantsStarted 2025-06-01

Plain-language 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. 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.

Who can participate

Age range

20 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * (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. Exclusion Criteria: * (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 com…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

live birth rate

Timeframe: within 12 months after initiating embryo transfer

Trial details

NCT IDNCT07039097

SponsorThe Third Xiangya Hospital of Central South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Dabao Xu

13017386201 forxudabao@126.com

View on ClinicalTrials.gov More Infertility and Miscarriage trials