Female Infertility Clinical Trial
Official title:
Histological and Transcriptional Changes Caused by Endometrial Flushing With Lipiodol: A Cross Over Study
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility |
Inclusion Criteria: - Women aged =18 and <36 years - Regular cycle (25-35 days) - Signed informed consent - Participants can be included only once in the trial - Contraceptive: barrier method only. Exclusion Criteria: - known iodine allergy - Body mass index 30 or =18.5 - Smoking - Previous diagnosis of PCO (Polycystic Ovary Syndrome) (>12 antral follicles in one ovary, Rotterdam criteria 2003) - Previous diagnosis of endometriosis, uterine malformations or intrauterine pathologies (submucosal fibroids, endometrial polyps, and intrauterine adhesions) - Systemic diseases such as thyroid dysfunction - Breast-feeding or pregnancy within the last 6 months - Intrauterine devices (IUD) - History of recurrent miscarriage - Known history of infertility - Previous uterine surgery - Pregnancy wish during the course of the study - Women who have been previously enrolled in the trial - Those unable to comprehend the investigational nature of the proposed study |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Brussel |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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) (a/ß), progesterone receptors (PR) (A, B), prolactine (PRL), insulin-like growth factor binding protein-1 (IGF-BP1), leukaemia inhibitory factor (LIF), Mucins (MUC1), integrin aVß3, vascular endothelial growth factor (VEG-F), transforming growth factor (TGF-ß1). | 7 days after LH peak | |
Primary | Transcriptional changes of the endometrium after Lipiodol bathing | RNA sequencing | 7 days after LH peak |
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