Recurrent Implantation Failure, T-Shaped Uterus
Conditions
Keywords
hysteroscopic metroplasty with cold scissiors, female infertility, recurrent implantation failure, reproductive outcome
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.
Interventions
PROCEDUREHysterocopic 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 treatment.
Sponsors
Shanghai First Maternity and Infant Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed