Infertility and Miscarriage
Conditions
Keywords
transcervical resection of septum, In Vitro Fertilization and Embryo Transfer
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.
Interventions
PROCEDURETranscervical resection of septum
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.
Sponsors
The Third Xiangya Hospital of Central South University
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
Hospital for Reproductive Medicine Affiliated to 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
Beijing Fuxing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse outcome rate | within 12 months after initiating embryo transfer in both groups | Pregnancy rate and cumulative pregnancy rate, miscarriage rate and cumulative miscarriage rate, preterm birth rate. |
Countries
China
Contacts
CONTACTDabao Xu
Outcome results
None listed