The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases
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|ClinicalTrials.gov Identifier: NCT00830401|
Recruitment Status : Terminated (Abnormality prevalence revealed to be much lower than expected.)
First Posted : January 27, 2009
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Minor Intra-uterine Abnormalities||Procedure: Treatment of predefined abnormality by hysteroscopic surgery Drug: Ofloxacinum/Doxycycline||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||March 2009|
No Intervention: 1
One or more of the predefined minor intra-uterine abnormalities have been detected, but not treated during hysteroscopy.
Active Comparator: 2
One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy.
Procedure: Treatment of predefined abnormality by hysteroscopic surgery
Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.
- Cumulative implantation rate [ Time Frame: One year ]
- Cumulative ongoing pregnancy [ Time Frame: One year ]
- Presence of minor uterine abnormalities [ Time Frame: At hysteroscopy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830401
|Utrecht, Netherlands, 3500VW|
|Study Chair:||Bart CJM Fauser, Prof. dr.||UMC Utrecht|
|Study Chair:||Paul Devroey, Prof. dr.||AZ-VUB|
|Study Director:||Frank JM Broekmans, Dr.||UMC Utrecht|
|Study Director:||Human M Fatemi, Dr.||AZ-VUB|
|Principal Investigator:||Jenneke C Kasius||UMC Utrecht|