Effect of Hysteroscopic Metroplasty on Reproductive Outcome in Patients with RIF

Not Applicable

• Conditions: Recurrent Implantation Failure; T-Shaped Uterus

• Registration Number: NCT06847386
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	From enrollment to the 18 months after the last embryo transfer	Proportion of patients whose blood β-hCG test is positive after embryo transfer

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy rate	From enrollment to the 18 months after the last embryo transfer	Proportion of patients who have elevated blood β-hCG (\> 25 mIU/mL) or positive urine immunopregnancy test, but ultrasound test reveal no gestational sac.
Clinical pregnancy rate	From enrollment to the 18 months after the last embryo transfer	Proportion of patients who have fetal primitive heart tube pulsation tested with ultrasonography 4 weeks after embryo transfer.
Fetal implantation rate	From enrollment to the 18 months after the last embryo transfer	Proportion of transfered embryos which develop into intrauterine gestational sacs.
Miscarriage rate	From enrollment to the 18 months after the last embryo transfer	Proportion of patients with unintentional termination of intrauterine pregnancy at 28 gestational weeks.

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shanghai, China