Endometrial Effects of Lipiodol

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.

Study Overview

• Status: Unknown
• Conditions: Female Infertility
• Intervention / Treatment: Device: Mock catheter; Drug: Lipiodol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sylvie De Rijdt, MD; Email: sylvie.derijdt@uzbrussel.be
• Study Contact Backup: Name: Christophe Blockeel, PhD; Phone Number: +3224776699; Email: christophe.blockeel@uzbrussel.Be

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Sylvie De Rijdt, MD; Email: sylvie.derijdt@uzbrussel.be
    • Contact: Christophe Blockeel, PhD; Phone Number: +3224776699; Email: christophe.blockeel@uzbrussel.Be
    • Principal Investigator: Christophe Blockeel, PhD
    • Principal Investigator: Annalisa Racca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; The control group wille have a mock catheter introduction between day 6 and 8 of the cycle without any Lipiodol flush	Device: Mock catheter; Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle
Experimental: Intervention group; The intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle	Drug: Lipiodol; Endometrial flushing with Lipiodol between day 6 and 8 of the cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Antineoplastic Agents; Ethiodized Oil
• Other Study ID Numbers: 2017.lipiodol.flush

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No