Clinical trial NCT06847386: Effect of Hysteroscopic Metroplasty on Reproductive Outcome in Patients with RIF
Official title: Research on the Effect of Hysteroscopic Metroplasty with Cold Scissors on Reproductive Outcome in Patients with Recurrent Implantation Failure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Recurrent Implantation Failure
T-Shaped Uterus
Keywords: hysteroscopic metroplasty with cold scissiors
female infertility
recurrent implantation failure
reproductive outcome
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Pregnancy rate
timeFrame: From enrollment to the 18 months after the last embryo transfer
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: From enrollment to the 18 months after the last embryo transfer
measure: Clinical pregnancy rate
timeFrame: From enrollment to the 18 months after the last embryo transfer
measure: Fetal implantation rate
timeFrame: From enrollment to the 18 months after the last embryo transfer
measure: Miscarriage rate
timeFrame: From enrollment to the 18 months after the last embryo transfer
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
References: