Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Frequency of tubal occlusion pre- and post-myomectomy
研究概览
简要总结
This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will test if the fallopian tubes are occluded or patent (open) before and after surgically removing fibroids.
Chromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction.
Open fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy.
This study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation.
详细描述
Background:
Fibroids have a prevalence >75%, making it the most common benign uterine disease [Zepiridis 2016, Lazaridis 2013, Giuliani 2020]. Fibroids are well known to contribute to infertility and early pregnancy loss [Don 2023, Pritts 2025, Carson 2021, Giuliani 2020]. This is typically thought to be secondary to distortion and impairment of the endometrial cavity or myometrial junction. However, it has been stressed in recent reviews that the full mechanism of the effect of fibroids on infertility is not fully understood, and more studies are needed [Donnez 2024]. It is theorized but not well confirmed through evidence-based studies that fibroids may also occlude or compress fallopian tubes and contribute to tubal occlusion that may contribute to infertility [Don 2023, Zepiridis 2016, Horne 2007, Somigliana 2021]. Additionally, up to 25-35% of female-factor infertility is related to tubal disease [ASRM Practice Committee 2021, Carson 2021, Mayrhofer 2022]. There is very little data on tubal patency assessment in patients undergoing myomectomy. The investigators have been able to identify only one prospective study from 1993 that specifically evaluated fallopian tube filling during post-myomectomy hysterosalpingogram, though the primary outcome of this study was endometrial cavity architecture [Lev-Toaff 1993]. Two recent retrospective studies have demonstrated a significant association between presence of leiomyoma and tubal occlusion in women with infertility [Mayrhofr 2024, Nako 2024]. Nako et al (2024) found a significant association only with submucosal fibroids. The investigators have not identified any recent prospective studies evaluating tubal patency in patients with uterine leiomyoma or those undergoing myomectomy.
Most data regarding tubal patency assessment are collected on patients already diagnosed with infertility, which introduces the possibility of multiple confounding variables. There are no recent prospective studies of tubal occlusion in patients with fibroids or patients undergoing myomectomy.
Earlier detection of tubal disease may allow for a quicker and more proactive work up and counseling before other factors such as age and oocyte quality further impact fertility options. There is also limited data on tubal occlusion or patency in patients with fibroids and those undergoing myomectomy. Underappreciation of the effect of uterine fibroids and myomectomy on tubal patency and subsequent delays in diagnosis could further complicate fertility due to age, reduced ovarian reserve and oocyte quality. Knowledge of tubal occlusion may influence referral to an infertility specialist or counseling for ectopic pregnancy risk.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing minimally invasive laparoscopic or robotic-assisted uterine-preserving gynecologic surgery for removal of uterine fibroids (myomectomy) by a minimally invasive gynecologic surgeon at MedStar.
排除标准
- •Patients with both fallopian tubes absent
- •Patients in whom it is not possible to place a uterine manipulator or catheter
- •Patient with known tubal disease or occlusion, or patients who have undergone prior tubal surgery
- •Patients with allergy to methylene blue dye or G6PD deficiency
- •Patients with positive pregnancy test on day of surgery
研究组 & 干预措施
ATOM study participants
Patients enrolled in the study who will undergo the chromopertubation per protocol
干预措施: chromopertubation (Procedure)
结局指标
主要结局
Frequency of tubal occlusion pre- and post-myomectomy
时间窗: Limited to the duration of each surgery
Frequency of tubal occlusion in patients with fibroids immediately prior to and after completion of myomectomy procedures. Spillage of methylene blue dye seen laparoscopically is indicative of tubal patency. Unilateral vs bilateral occlusion will be documented.
次要结局
- Frequency of tubal occlusion compared to fibroid characteristics(Limited to the duration of each surgery)
- Change in tubal occlusion(Limited to the duration of each surgery)