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临床试验/NCT07143578
NCT07143578招募中不适用

Comparison Of Surgical Management Of Early Pregnancy Loss By Suction Curettage Versus Hysteroscopy In Patients Undergoing In-Vitro Fertilization (IVF)

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Intrauterine adhesions

研究概览

简要总结

Early pregnancy loss occurs in ~15% of pregnancies. The treatment options include surgical uterine evacuation by suction curettage, medical management with misoprostol, or conservative management without interventions. The advantages of surgical management include quick resolution of the pregnancy and avoidance of heavy vaginal bleeding, while the disadvantages include retained products of conception and intrauterine adhesion formation which could affect future fertility. With the aim of reducing the complications of suction curettage, uterine evacuation using operative hysteroscopy has been suggested.

In a previous study, the investigators compared suction curettage with operative hysteroscopy for the surgical management of early pregnancy loss up to 10 weeks of gestation. The results showed significantly reduced adhesions rate (4.2% in the hysteroscopy group vs. 45.2% in the suction group, p < 0.01), although the operative time was significantly longer for the hysteroscopy.

In this follow-up study, the investigators will compare the outcomes of hysteroscopy and suction curettage in a select group of patients with early pregnancy loss following conception by in-vitro fertilization. These patients are at risk for adhesions and therefore candidates for the hysteroscopic intervention. The study will include 50 patients randomized to 2 intervention arms - hysteroscopy using a tissue removal device versus the standard suction curettage. Post-operative adhesions will be assessed by office hysteroscopy after 6-8 weeks.

详细描述

The treatment options for early pregnancy loss include surgical uterine evacuation by suction curettage, medical management with misoprostol, and expectant (conservative) management. The advantages of surgical evacuation include quick resolution of the pregnancy and prevention of heavy bleeding that could necessitate urgent curettage. Although suction curettage is a common and relatively safe procedure, it carries short term risks such as infection, retained products of conception requiring repeat surgery, hemorrhage, and uterine perforation. Long term complications include intrauterine adhesions (also known as Asherman's syndrome), which may impair fertility. In recent years, the option of uterine evacuation by operative hysteroscopy has been investigated. Hysteroscopy enables a visual inspection of the uterine cavity (as opposed to the blind suction curettage), and involves a targeted and limited contact with the endometrium, possibly reducing adhesion formation compared to the "global" suction curettage.

Previous studies indeed found that hysteroscopy was feasible and safe for the surgical management of early pregnancy loss. The investigators recently completed a prospective RCT comparing suction curettage and operative hysteroscopy in 100 women diagnosed with early pregnancy loss up to 10 weeks of gestation. The results showed a significantly lower rate of intrauterine adhesions in the hysteroscopy group (4.2% vs. 45.2%, p < 0.01). However, operative time was significantly longer for the hysteroscopy. There were no significant differences between groups in the rates of retained products of conception or surgical complications.

Although the study did not address the cost of the different surgical techniques, hysteroscopy is obviously more expensive and requires specialized equipment and skilled surgeons. Thus, operative hysteroscopy is likely more applicable for selected patients at risk for intrauterine adhesions and impaired fertility.

Patients undergoing in-vitro fertilization (UVF) represent a unique population with higher baseline risk for intrauterine adhesions due to prior uterine procedures and repeated curettage. Hooker et al. demonstrated that adhesions could cause impair embryo implantation, thereby reducing the rate of successful IVF cycles. Deng et al. showed that delaying embryo transfer after adhesiolysis improves live birth rates.

In view of the impact of adhesions on fertility and the potential to delay pregnancy, selecting the optimal surgical method is especially important for IVF patients diagnosed with early pregnancy loss, and these patients may benefit specifically from the hysteroscopic procedure.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of early pregnancy loss up to 10 weeks' gestation, based on last menstrual period or ultrasound.
  • Pregnancy conceived through assisted reproductive techniques (in vitro fertilization, IVF).
  • Ability to provide informed consent, and proficiency in reading and writing Hebrew.

排除标准

  • Heavy vaginal bleeding or diagnosis of incomplete abortion.
  • Signs of infection and/or suspicion of septic abortion
  • Known uterine anomalies- including septate, bicornuate, unicornuate, or didelphys uterus.
  • Prior medical or surgical treatment during the current pregnancy
  • History of intrauterine adhesions
  • History of ≥ 3 prior miscarriages.
  • History of ≥ 3 prior cesarean sections.
  • History of myomectomy via abdominal or hysteroscopic approach.

研究组 & 干预措施

Operative hysteroscopy

Experimental

Operative hysteroscopy using tissue removal device

干预措施: Operative hysteroscopy using tissue removal device (Device)

Suction curretage

Active Comparator

Standard suction curettage

干预措施: suction curettage (Device)

结局指标

主要结局

Intrauterine adhesions

时间窗: 8 weeks

Post-operative intrauterine adhesions will be evaluated by office diagnostic hysteroscopy after 6-8 weeks. The physician performing the office hysteroscopy will be blinded to the patient's intervention arm. The intrauterine adhesions will be classified according to the American Fertility Society score (from 0 to 12, higher scores means worse adhesions).

Time to pregnancy

时间窗: 12 months

The patient's reproductive outcomes will be assessed by telephone interview after 6 and 12 months from the intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Noam Smorgick

Director of MIGS

Assaf-Harofeh Medical Center

研究点 (2)

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