NCT00830401

The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases

Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: Female
• Age: 36 Years
• Healthy volunteers: Accepted

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.

Conditions

• Minor Intra-uterine Abnormalities

Interventions

Type	Name	Description
PROCEDURE	Treatment 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
DRUG	Ofloxacinum/Doxycycline	Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-11-01
• Completion: 2009-03-01
• First posted: 2009-01-27
• Last updated: 2015-06-04

Locations

1 site across 1 country: Netherlands