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

Phase 2

Terminated

• Conditions: Minor Intra-uterine Abnormalities
• Interventions: Procedure: Treatment of predefined abnormality by hysteroscopic surgery; Drug: Ofloxacinum/Doxycycline

• Registration Number: NCT00830401
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-11
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Study Completion: 2009-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Treatment of predefined abnormality by hysteroscopic surgery	One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy.
2	Ofloxacinum/Doxycycline	One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Cumulative implantation rate	One year

Secondary Outcome Measures

Name	Time	Method
Cumulative ongoing pregnancy	One year
Presence of minor uterine abnormalities	At hysteroscopy

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands