Endometrial Diseases, Infertility
Conditions
Keywords
Recurrent implantation failure, Endometrial injury, Implantation, Hysteroscopy
Brief summary
The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.
Detailed description
This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.
Interventions
PROCEDUREEndometrial Injury with Hysteroscopy
All office hysteroscopy procedures will be done transvaginally under sedation with a 5 mm 30 degree lens supplied with a 5 F working channel continuous flow office hysteroscope (Bettocchi office hysteroscope, Karl Storz, Tuttlingen, Germany) without speculum or tenaculum. Briefly, following cervical passage and initial endometrial cavity investigation endometrial injury will be performed without energy modality (i.e. with scissors). Endometrial injury will perform first on the fundus by cutting into the endometrium (without injuring the myometrium) transversally. Later, vertical incisions will perform 0,5 cm apart each other, on the anterior and posterior walls of the uterus, 1-1.5 cm away from the fundus and one cut for each lateral wall
Sponsors
Gurgan Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women under the age of 40 who met the RIF definition * Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL
Exclusion criteria
* Patients with congenital uterine anomalies * Patients with Asherman's syndrome * Patients with uterine cavity distorted by myoma or endometrial polyps * Patients with confirmed endometriosis or endometrioma * Patients with BMI of \<18.5 and \>29.9
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Pregnancy | 1month | Blood concentration of beta-hcg |
Countries
Turkey (Türkiye)
Contacts
Primary ContactTimur Gurgan, MD,Professor
Backup ContactMuberra Namlı Kalem, MD
Outcome results
None listed