Endometrial Effects of Lipiodol

Female Infertility Clinical Trial

Official title:

Histological and Transcriptional Changes Caused by Endometrial Flushing With Lipiodol: A Cross Over Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03542331
• Other study ID #: 2017.lipiodol.flush
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

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