Effect of Hysteroscopic Metroplasty on Reproductive Outcome in Patients with RIF

NCT06847386 | Enrolling By Invitation

• 1 other identifier: 22Y11906100
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Implantation Failure; T-Shaped Uterus

Keywords

hysteroscopic metroplasty with cold scissiors; female infertility; recurrent implantation failure; reproductive outcome

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  Proportion of patients whose blood β-hCG test is positive after embryo transfer

  From enrollment to the 18 months after the last embryo transfer

Secondary Outcomes (4)

• Biochemical pregnancy rate

  From enrollment to the 18 months after the last embryo transfer

• Clinical pregnancy rate

  From enrollment to the 18 months after the last embryo transfer

• Fetal implantation rate

  From enrollment to the 18 months after the last embryo transfer

• Miscarriage rate

  From enrollment to the 18 months after the last embryo transfer

Study Arms (2)

Direct Embryo Transfer

NO INTERVENTION

Patients in this group receive embryo transfer without hysteroscopy

Hysteroscopy

EXPERIMENTAL

Patients in this group receive hysteroscopic examination. If T-shaped uterus is diagnosed during the operation, hysteroscopic metroplasty will be performed.

Procedure: Hysterocopic metroplasty

Interventions

Hysterocopic metroplasty PROCEDURE

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 treatment.

Hysteroscopy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: January 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)