Effect of Hysteroscopic Metroplasty on Reproductive Outcome in Patients with RIF

Официальное название

Research on the Effect of Hysteroscopic Metroplasty with Cold Scissors on Reproductive Outcome in Patients with Recurrent Implantation Failure

Обзор

In recent years with the continuous improvement of ART technology, it has brought new hope to infertile couples, however more than half of the patients still experience multiple transfer failures. Abnormalities in the structure of the uterine cavity are one of the main factors that lead to the failure of embryo implantation. Hysteroscopic metroplasty with cold scissors is an innovative technique of our team, in which micro-scissors are used in the procedure instead of the previous electric knife. Our previous study found that this technique has the effect of improving fertility outcomes in patients with T-shaped uterus. Based on the previous study, this study is an open randomized controlled trial to include patients with more than 2 or more ART implantation failures. For the first time, cold knife hysteroscopic hysterectomy was used to treat patients with cryptic uterine stenosis in patients with repeated RIF implantation failures to assess the clinical efficacy of the technique and to investigate the effect of this technique on the pregnancy outcome of reimplantation of embryos in patients with repeated ART implantation failures. Meanwhile, this project is the first to study the diagnostic value of transvaginal 3D ultrasound/MRI for the assessment of uterine cavity status in patients with RIF, with a view to exploring the value of noninvasive imaging as an alternative to invasive hysteroscopy in the clinical management of RIF. The aim of the study is to provide a reference for early diagnosis and treatment of patients with repeated ART implantation failures, and to improve the pregnancy outcome of their reimplanted embryos.

Вмешательства

• Процедура Hysterocopic metroplasty
  If the uterine cavity is normal during intraoperative hysteroscopy, the operation will be finished and embryo transfer will be scheduled in 1 month after the operation; if the uterine cavity is narrowed or the uterine wall is coalesced, hysteroscopic metroplasty and IUD placement will be performed, and a second hysteroscopy with IUD retrieval will be performed after 2-month postoperative estrogen-progesterone treatment, then embryo transfer will be scheduled after 1-month estrogen-progesterone t

Первичные конечные точки

• Pregnancy rate [Срок оценки: From enrollment to the 18 months after the last embryo transfer]

Вторичные конечные точки (4)

• Biochemical pregnancy rate [Срок оценки: From enrollment to the 18 months after the last embryo transfer]
• Clinical pregnancy rate [Срок оценки: From enrollment to the 18 months after the last embryo transfer]
• Fetal implantation rate [Срок оценки: From enrollment to the 18 months after the last embryo transfer]
• Miscarriage rate [Срок оценки: From enrollment to the 18 months after the last embryo transfer]

Критерии участия

Критерии включения

• At least twice previous implantation failures
• Willing to receive further embryo transfer

Критерии исключения

• Sturctural intrauterine lesions
• Severe adenomyosis
• Premature ovarian failure
• BMI > 35 kg/m\^2
• Severe systemic disease or maligant tumor

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai First Maternity and Infant Hospital — Шанхай

Идентификаторы

NCT: NCT06847386 · 22Y11906100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗