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Enrolling by Invitation

NCT Number: NCT06847386

Effect of Hysteroscopic Metroplasty on Reproductive Outcome in Patients with RIF

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pregnancy rate

    Time frame: 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 outcomes

  1. Biochemical pregnancy rate

    Time frame: 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.

  2. Clinical pregnancy rate

    Time frame: 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.

  3. Fetal implantation rate

    Time frame: From enrollment to the 18 months after the last embryo transfer

    Proportion of transfered embryos which develop into intrauterine gestational sacs.

  4. Miscarriage rate

    Time frame: From enrollment to the 18 months after the last embryo transfer

    Proportion of patients with unintentional termination of intrauterine pregnancy at 28 gestational weeks.

Sponsors and collaborators

Lead sponsor

Shanghai First Maternity and Infant Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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