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Abnormality prevalence revealed to be much lower than expected.
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| Name | Class |
|---|---|
| Universitair Ziekenhuis Brussel | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | One or more of the predefined minor intra-uterine abnormalities have been detected, but not treated during hysteroscopy. | |
| 2 | Active Comparator | One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment of predefined abnormality by hysteroscopic surgery | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative implantation rate | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative ongoing pregnancy | One year | |
| Presence of minor uterine abnormalities | At hysteroscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bart CJM Fauser, Prof. dr. | UMC Utrecht | Study Chair |
| Paul Devroey, Prof. dr. | Universitair Ziekenhuis Brussel | Study Chair |
| Frank JM Broekmans, Dr. | UMC Utrecht | Study Director |
| Human M Fatemi, Dr. | Universitair Ziekenhuis Brussel | Study Director |
| Jenneke C Kasius | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Utrecht | Utrecht | 3500VW | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23499151 | Derived | Smit JG, Kasius JC, Eijkemans MJ, Veersema S, Fatemi HM, Santbrink van EJ, Campo R, Broekmans FJ. The international agreement study on the diagnosis of the septate uterus at office hysteroscopy in infertile patients. Fertil Steril. 2013 Jun;99(7):2108-13.e2. doi: 10.1016/j.fertnstert.2013.02.027. Epub 2013 Mar 13. |
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|
| Ofloxacinum/Doxycycline | Drug | Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days. |
|
| ID | Term |
|---|---|
| D011127 | Polyps |
| D009214 | Myoma |
| D000267 | Tissue Adhesions |
| D004716 | Endometritis |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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