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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Minor Intra-uterine Abnormalities

Intervention / Treatment
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* Procedure: Treatment of predefined abnormality by hysteroscopic surgery
* Drug: Ofloxacinum/Doxycycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>One or more of the predefined minor intra-uterine abnormalities have been detected, but not treated during hysteroscopy. | |
| Active Comparator: 2<br>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<br>* 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<br>Drug: Ofloxacinum/Doxycycline<br>* Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative implantation rate |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative ongoing pregnancy |  | One year | 
| Presence of minor uterine abnormalities |  | At hysteroscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-uterine abnormalities, intracavitary pathology, hysteroscopy, IVF, ICSI, polyp, myoma, adhesion, septum, endometritis