Minor Intra-uterine Abnormalities
Conditions
Keywords
intra-uterine abnormalities, intracavitary pathology, hysteroscopy, IVF, ICSI, polyp, myoma, adhesion, septum, endometritis
Brief summary
This is a comparative, controlled trial to evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.
Detailed description
Introduction- Implantation failure after IVF may be due to endometrial function, embryo quality or a combination of both. The prevalence of minor intracavitary pathology in cases with an apparent normal transvaginal sonography (TVS) observed at hysteroscopy has been recorded to be 25-40%. Treatment of such pathology prior to initiating IVF/ICSI has been advocated without high-quality evidence. Objective- To evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment. Material & methods- Patients, indicated for their first IVF/ICSI treatment cycle at the UMC Utrecht and AZ-VUB Brussels, initially underwent TVS. In case of a normal TVS these patients were scheduled for hysteroscopy in the early-mid follicular phase of the cycle, one to three months before starting IVF/ICSI treatment. Vaginoscopic hysteroscopy was performed in an ambulatory office setting. During the hysteroscopy a biopsy was taken, to diagnose chronic endometrial inflammation. In case of finding a predefined intra uterine abnormality (polyp, myoma, adhesion, septum, endometrial inflammation) randomisation took place if prior to hysteroscopy informed consent had been obtained for endoscopy treatment versus no treatment. Shortly after the hysteroscopy, IVF/ICSI treatment was initiated and outcome during one year treatment period will be recorded.
Interventions
PROCEDURETreatment of predefined abnormality by hysteroscopic surgery
* Polyp resection with Hysteroscopic scissors or Versapoint * Resection of myoma with Resectoscope Storz or Versapoint * Septum resection with Resectoscope Storz or Versapoint * Resection of adhesions with Hysteroscopic scissors or Versapoint
DRUGOfloxacinum/Doxycycline
Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.
Sponsors
AZ-VUB
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 36 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal Transvaginal Ultrasound * No prior hysteroscopy * Regular menstrual cycle * Single embryo transfer * BMI between 18 and 29 * Presence of both ovaries * Primary or secondary infertility * Women indicated for a first IVF/ICSI cycle
Exclusion criteria
* Recurrent miscarriage * Prior hysteroscopic treatments * Endometriosis \> AFS Stage II * Meno-metrorrhagia (defined as any intermenstrual loss of blood) * Submucosal/Intracavitary Fibroids taking more than 50% of the cavity * Hydrosalpinx * FSH/LH \> 12IU/L on day 3 * Polyps taking more than 50% of the cavity * Severe adhesions \> grade II
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative implantation rate | One year |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative ongoing pregnancy | One year |
| Presence of minor uterine abnormalities | At hysteroscopy |
Countries
Netherlands
Outcome results
None listed