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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03542331
Other study ID # 2017.lipiodol.flush
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 1, 2018
Est. completion date January 2020

Study information

Verified date May 2019
Source Universitair Ziekenhuis Brussel
Contact Christophe Blockeel, PhD
Phone +3224776699
Email christophe.blockeel@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lipiodol
Endometrial flushing with Lipiodol between day 6 and 8 of the cycle
Device:
Mock catheter
Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle

Locations

Country Name City State
Belgium Universitair Ziekenhuis Brussel Brussel

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

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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