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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
China
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
Dabao Xu
forxudabao@126.com
13017386201
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2030-06-01
Participants
Target number of participants: 418
Treatments
Experimental: Surgical group
Undergoing Transcervical resection of septum
No_intervention: Control group
Routine preconception counseling and observation without hysteroscopic septectomy
Related Therapeutic Areas
Sponsors
Collaborators: Anhui Provincial Hospital, Peking Union Medical College Hospital, Maternal and Child Health Hospital of Hubei Province, Xijing Hospital, Beijing Tiantan Hospital, Women's Hospital School Of Medicine Zhejiang University, Obstetrics & Gynecology Hospital of Fudan University, Shandong University, Gansu Provincial Maternal and Child Health Care Hospital, Tongji Hospital, Tianjin Medical University General Hospital, The First Hospital of Jilin University, The First People's Hospital of Yunnan, Southwest Hospital, China, Guangzhou First People's Hospital, Beijing Fuxing Hospital
Leads: The Third Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov

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