Minor Intra-uterine Abnormalities Clinical Trial
Official title:
Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment