Female Infertility
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLipiodol
Endometrial flushing with Lipiodol between day 6 and 8 of the cycle
DEVICEMock catheter
Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomo-pathological changes of the endometrium after Lipiodol bathing | 7 days after LH peak | 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. |
| Histochemical changes of the endometrium after Lipiodol bathing | 7 days after LH peak | 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). |
| Transcriptional changes of the endometrium after Lipiodol bathing | 7 days after LH peak | RNA sequencing |
Countries
Belgium
Contacts
Primary ContactChristophe Blockeel, PhD
Backup ContactSylvie De Rijdt, MD
Outcome results
None listed