The Impact of Myomectomy on IVF Outcomes: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 792
- 主要终点
- Number of participants with live birth after IVF within one year
研究概览
简要总结
In 2% to 3% infertility women, myoma is the only factor relevant to their infertility. However, the effects of intramural myoma on fertility are controversial. For infertile women with intramural myoma (types IV, V, VI of FIGO system) of 4 to 6 cm diameter, it is not clear whether myomectomy could improve pregnancy outcomes, especially in women undergoing ART. Besides, rigorous clinical research is needed to explore the changes and relevant biomarkers of endometrial receptivity through multi-omics study in patients undergoing myomectomy and ART treatment.
Method Intervention and follow-up: (1) For the control group, evaluation protocols such as salpingography and/or laparoscopic tubal fluxation should be implemented to identify disorders such as hydrosalpinx. (2) Imaging evaluation: all pelvic MRI were performed. Other options such as transvaginal ultrasound are not excluded, but won't replace MRI. Enhanced MRI or DWI may be considered, but are not always required. (3) Surgical intervention: laparoscopic myomectomy is preferred, and abdominal myomectomy is also acceptable. (4) IVF treatment: the IVF regimen should include detailed records of the downregulation plan, number of cycles, frozen or fresh blastocysts.
Study endpoints
(1) Primary study endpoint: Live birth rate after IVF. (2) Secondary study endpoints: Clinical pregnancy rate after IVF; Cumulative pregnancy rate after IVF; Biochemical pregnancy rate after IVF; Sustained pregnancy rate after IVF (≥20 weeks); Miscarriage rate after IVF; Cycles of IVF; Pregnancy-related complications; Perinatal maternal and neonatal complications. (3) Exploratory endpoints: The correlation between imaging index and assisted reproductive outcomes, including endometrial thickness, uterine volume, type of endometrial echo, uterine contraction; endometrial vascular index (VI), flow index (FI), tubular flow index (VFI); uterine artery pulsation index (PI), uterine artery resistance index (RI), systolic/diastolic blood pressure of uterine artery (S/D).
The correlation between endometrial receptivity and assisted reproductive outcomes is analyzed based on transcriptomics, metabolomics, methylation and proteomics in samples from peripheral blood, endometrial biopsy, endometrial exfoliated cells, cervical exfoliated cells and myoma.
详细描述
Grouping and blinding method This is a national multicenter, randomized controlled study. Competitive enrollment is performed among all centers. The study group received IVF after myomectomy and the control group was directed to IVF after the routine evaluation, probably including diagnostic laparoscopy. In this study, 792 patients were randomly divided into 2 groups with 396 patients in each group according to centralized random system. A random sequence is generated with a random block size of a block size of 4.
Collection of clinical data and samples Data and samples are collected according to Case Report Form (CRF) form, including randomized information, epidemiologic and clinical information. Evaluation of infertility history and details, imaging results, ovarian reservation and surgical findings are of special interest and detailed recorded.
Samples of peripheral blood, cervical exfoliated cells, endometrial exfoliated cells, endometrial biopsy and myoma in study group are collected for multi-omics analysis. The process of sample harvest shouldn't interfere or deteriorate the surgical and IVF treatment.
IVF treatment: the IVF regimen should include detailed records of the downregulation plan, number of cycles, frozen or fresh blastocysts, ①Study group: IVF treatment is performed 6 months after myomectomy, and patients should be followed up for 1 year after the start of IVF. If the endometrium is exposed during myomectoy, IVF treatment is performed 12 months after myomectomy. It should be noted that the time for postoperative contraception should be recorded, and also the time interval between myomectomy and IVF.
②Control group: IVF treatment was performed immediately after relevant evaluation, and follow-up for 1 year after the start of IVF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged between 20-40 years old.
- •Primary or secondary infertility consisting of following factors rather than uterine factors: male factors, ovulation disorders, fallopian tube factors, endometriosis, other non-uterine factors including infertility with unexplained reason.
- •Myoma: FIGO type 4-6 discovered by MRI with the maximum diameter surgically targeted between 4-6cm; Single myoma, or multiple myomas with non-surgically targeted intramural or subserous myoma(s) < 2cm in maximum diameter.
- •Justifying the IVF criteria and willing to undergo IVF.
排除标准
- •Not meeting all the inclusion criteria.
- •Complicated with infertility factors of uterine factors or diseases, including adenomyosis, endometrial adhesion, endometritis, submucous myoma. However, resectable endometrial polyps need not be excluded.
- •Complicated with malignancies or borderline tumors of the reproductive tract
- •Complicated with other malignancies not been treated or still being treated.
- •Complicated with active pelvic inflammatory disease.
- •Previously receiving cytotoxic therapy or abdominal-abdominal chemoradiotherapy.
- •Previous uterine body surgery, including but not limited to: myomectomy, resection for adenomyosis lesions, uterine artery embolization, uterine tumor coagulation (high energy focused ultrasound or electrocoagulation, hysteroscopically myomectomy. However, diagnostic hysteroscopy, diagnostic curettage and polypectomy need not be excluded.
- •No willing to undergo IVF.
- •Unable to be followed-up.
结局指标
主要结局
Number of participants with live birth after IVF within one year
时间窗: one year after IVF
Live birth rate after IVF in infertility patients with intramural myoma (types IV, V, VI) with a diameter of 4-6cm receiving or not receiving myomectomy.
次要结局
- Number of participants with of clinical pregnancy after IVF within one year(one year after IVF)
- Number of participants with pregnancy-related complications(one year after IVF)
- Number of participants with miscarriage after IVF(one year after IVF)
- Number of participants with sustained pregnancy rate after IVF (≥20 weeks)(at least 20 weeks after IVF)
- number of cycles of IVF(one year after IVF)
- Number of participants with cumulative pregnancy after IVF within one year(one year after IVF)
- Number of participants with Biochemical pregnancy rate after IVF(one year after IVF)
- Number of participants with perinatal maternal and neonatal complications(one year after IVF)