Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

Last updated: September 10, 2021
Sponsor: Limin Feng
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04972032
E-IUS
  • Ages 18-40
  • Female

Study Summary

This is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an Estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patients aged 18-40 years;
  • Meets the diagnostic criteria for moderate to severe uterine adhesions;
  • Has the indication for TCRA surgery and is intending to undergo TCRAsurgery;
  • Female subjects are not breastfeeding at the time of the screeningvisit; ⑤ Voluntary acceptance of the treatment and has signed theinformed consent form.

Exclusion

Exclusion Criteria:

  • Known allergic reactions to or contraindications for silicone rubber materials,estradiol and its metabolites, Foley balloon catheters and/or intrauterinecross-linked sodium hyaluronate gel;
  • Presence of contraindications for TCRA surgery;
  • Requires oral hormonal medications for a prolonged period of time;
  • Has used high-dose estrogen medication within one month prior tosurgery;
  • Suffering from diseases such as genital tract tuberculosis, acutegenital tract inflammation, pelvic inflammatory disease, abnormaluterine bleeding caused by systemic disease or malignant tumoursof the genital organs; ⑥ Perimenopausal and menopausal females; ⑦ Comorbid with severe primary diseases of the cardiovascular,cerebrovascular, hepatic, renal or hematopoietic system, or pepticulcer disease, or severe diseases affecting patient survival (suchas tumours or AIDS), or mental illness; ⑧ Drug or alcohol dependence; ⑨ Has enrolled in other clinical trials within the last 1 month; ⑩ Patients with factors considered by the investigators to beunsuitable for enrollment.

Study Design

Total Participants: 246
Study Start date:
September 02, 2020
Estimated Completion Date:
March 31, 2025

Study Description

Patients suspect to be suffering from IUA will be recruited following a systematic pre-operative assessment process. This will include a detailed history of the menstrual pattern, previous intrauterine surgery, and reproductive history, as well as 3D transvaginal ultrasound. The severity and extent of intrauterine adhesions will be scored according to the AFS score. All patients will receive hysteroscopic adhesiolysis with the aid of ultrasound guidance as necessary. After adhesiolyis, the patients will assigned to two groups randomly,namely,the E-IUS(estrogen intrauterine stent system) group and the control group. Adhesion will be evaluated by hysteroscopy at second-look hysteroscopy before 60 after surgery.

Connect with a study center

  • YiPuRun (Shanghai) Biotechnology Co.,Ltd.

    Shanghai, Shanghai
    China

    Active - Recruiting

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