PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 24
- 主要终点
- Efficacy - IUA Severity
研究概览
简要总结
PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf
详细描述
PREG2 is a prospective, multi-center, randomized, controlled, two arm clinical study. The objective is to evaluate the efficacy of Womed Leaf in preventing intrauterine adhesion recurrence after adhesiolysis compared to adhesiolysis alone.
The study will be performed on women with moderate or severe adhesions (AFS score >=5) scheduled for adhesiolysis. Indeed, the risk of intrauterine adhesion is very high (up to 60%) in this population of patients.
A follow-up diagnostic hysteroscopy will be performed 6-8 weeks after the adhesiolysis procedure to determine the presence and severity of IUAs according to the American Fertility Society and European Society of Gynecologic Endoscopy classification systems of adhesions. Fertility-related outcome will include live pregnancy at 1 year, 2 years and 3 years and will be reported as secondary endpoints. 154 women are planned to be included in the PREG2 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Women with moderate or severe intrauterine adhesions according to the AFS classification, i.e AFS score >=5, confirmed by hysteroscopy right before adhesiolysis
- •Scheduled for hysteroscopic adhesiolysis
- •Age above or equal to 18
- •Subjects who are willing to provide a written informed consent.
- •Subjects who can comply with the study follow-up (second look hysteroscopy) and other study requirements
- •Subjects who agree to refrain from intercourse or use a reliable form of barrier contraception to prevent unintended pregnancy until the follow-up hysteroscopy.
- •Subjects who agree to avoid all intrauterine devices (IUDs) until the follow-up hysteroscopy.
排除标准
- •Pre-operative criteria
- •Post menopause
- •Pregnant (confirmed by a positive pregnancy test) or lactating
- •Abnormal uterine cavity according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
- •Known or suspected endometrial hyperplasia
- •History of cervical or endometrial cancer
- •Active pelvic infection or history of pelvic peritonitis
- •History of endometrial ablation
- •Known contraindication or hypersensitivity to Womed Leaf component
- •Current participation in another clinical investigation that has not yet received the primary endpoint.
- •Any other condition that makes participation in the study contrary to the patient's best interests.
- •Intra-operative criteria, post adhesiolysis:
- •Perforation during adhesiolysis
- •Uterine depth < 5cm or > 10cm
结局指标
主要结局
Efficacy - IUA Severity
时间窗: At second look hysteroscopy between 4 and 8 weeks
Change of AFS score between pre-adhesiolysis and second-look hysteroscopy (AFS) score The scale used to assess the severity of intrauterine adhesions is the American Fertility Society score. It is a 12 points composite score that adds-up 3 subcomponents: - Extend of adhesions (1 = less than 1/3 of the uterine cavity involved with adhesions to 4 = more than 2/3 of the uterine cavity involved with adhesions), * Type of adhesions (1 = Filmy adhesions to 4 = dense adhesions) * Menstrual pattern (0= normal to 4 = amenorrhea). The final score allows the following prognostic classification: 1-4 = mild disease, 5-8 = moderate disease 9-12 = severe disease
Safety - Adverse Events
时间窗: At second look hysteroscopy between 4 and 8 weeks
Adverse events up to second look hysteroscopy.
次要结局
- High-responder Rate(At second look hysteroscopy between 4 and 8 weeks)
- Change of "Extent of Cavity Involved" Component(At second look hysteroscopy between 4 and 8 weeks)
- Change in "Extent of Cavity Involved" Component Between Post-adhesiolysis and Second Look Hysteroscopy(At second look hysteroscopy between 4 and 8 weeks)
- AFS Score(At second look hysteroscopy between 4 and 8 weeks)
- Change of Extent of IUA AFS Score Component(At second look hysteroscopy between 4 and 8 weeks)
- Change of Type of IUA AFS Score Component(At second look hysteroscopy between 4 and 8 weeks)
- Menstrual Pattern AFS Score Component(At second look hysteroscopy between 4 and 8 weeks)
- Percentage of Patients Who Have Mild Adhesions or no Adhesion(At second look hysteroscopy between 4 and 8 weeks)
- Freedom From IUA(At second look hysteroscopy between 4 and 8 weeks)
- ESGE Stage(At second look hysteroscopy between 4 and 8 weeks)
- Level of Post-operative Pain(At second look hysteroscopy between 4 and 8 weeks)
- Level of Discomfort Related to Vaginal Discharge(At second look hysteroscopy between 4 and 8 weeks)
- Timing of Vaginal Discharge(At second look hysteroscopy between 4 and 8 weeks)
- Duration of the Vaginal Discharge(At second look hysteroscopy between 4 and 8 weeks)
- Qualitative Description of the Vaginal Discharge(At second look hysteroscopy between 4 and 8 weeks)
- Change of Menstrual Pattern(At second look hysteroscopy between 4 and 8 weeks, 1 year, 2 years)
- Reintervention Rate(At second look hysteroscopy or scheduled later up to one year)
- Number of Adhesiolysis Procedures(After second look to one year)
- Pregnancy Rate(1 year, 2 years, 3 years)
- Live Birth Rate(1 year 2 years, 3 years)
- Pregnancy Complication Rate(3 years)
- Time to Pregnancy(3 years)
- IUA Severity According to Chinese Scoring System(At second look hysteroscopy between 4 and 8 weeks)
- Responder Rate(At second look hysteroscopy between 4 and 8 weeks)