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The goal is to investigate whether endometrial flushing with Lipiodol enhances fertility. Therefore, anatomo-pathological, histochemical and transcriptional changes of the endometrium after Lipiodol bathing in a general population of healthy volunteers will be determined.
A single-centre, cross-over, open-label trial will be performed. Healthy volunteers, fulfilling the inclusion/exclusion criteria, will be asked to do blood samples and ultrasounds for the detection of the LH (luteinizing hormone) surge in a natural cycle. The intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle, while the control group between day 6 and 8 of the cycle will have a mock catheter introduction without any Lipiodol flush. An endometrial biopsy will be performed 7 days after the LH peak in all the participants. Furthermore, all the participants will undergo one cycle with flushing and one cycle with introduction of a mock catheter but without flushing with any medication. The wash-out period between the 2 biopsies will be 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | The control group wille have a mock catheter introduction between day 6 and 8 of the cycle without any Lipiodol flush |
|
| Intervention group | Experimental | The intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipiodol | Drug | Endometrial flushing with Lipiodol between day 6 and 8 of the cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomo-pathological changes of the endometrium after Lipiodol bathing | To determine whether the treatment with lipiodol alters the leukocyte population. Changes in the uterine dendritic cell population, collections of macrophages and an increased number of inflammatory cells will be investigated. A sub-ephitelial re-location of lymphocytes (CD3-CD7 and CD8 (CD: Cluster of Differentiation)) will be looked for. | 7 days after LH peak |
| Histochemical changes of the endometrium after Lipiodol bathing | The immunohistochemistry for the key implantation factors, the subsequent molecular markers will be examined: estrogen receptors (ER) (α/β), progesterone receptors (PR) (A, B), prolactine (PRL), insulin-like growth factor binding protein-1 (IGF-BP1), leukaemia inhibitory factor (LIF), Mucins (MUC1), integrin αVβ3, vascular endothelial growth factor (VEG-F), transforming growth factor (TGF-β1). | 7 days after LH peak |
| Transcriptional changes of the endometrium after Lipiodol bathing | RNA sequencing | 7 days after LH peak |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe Blockeel, PhD | Contact | +3224776699 | christophe.blockeel@uzbrussel.be | |
| Sylvie De Rijdt, MD | Contact | sylvie.derijdt@uzbrussel.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 |
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| Mock catheter |
| Device |
Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle |
|
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |