Endometrial Effects of Lipiodol
Primary Purpose
Female Infertility
Status
Unknown status
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Lipiodol
Mock catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Female Infertility
Eligibility Criteria
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
Sites / Locations
- Universitair Ziekenhuis BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control group
Intervention group
Arm Description
The control group wille have a mock catheter introduction between day 6 and 8 of the cycle without any Lipiodol flush
The intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle
Outcomes
Primary Outcome Measures
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.
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).
Transcriptional changes of the endometrium after Lipiodol bathing
RNA sequencing
Secondary Outcome Measures
Full Information
NCT ID
NCT03542331
First Posted
April 13, 2018
Last Updated
May 3, 2019
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT03542331
Brief Title
Endometrial Effects of Lipiodol
Official Title
Histological and Transcriptional Changes Caused by Endometrial Flushing With Lipiodol: A Cross Over Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
The control group wille have a mock catheter introduction between day 6 and 8 of the cycle without any Lipiodol flush
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle
Intervention Type
Drug
Intervention Name(s)
Lipiodol
Intervention Description
Endometrial flushing with Lipiodol between day 6 and 8 of the cycle
Intervention Type
Device
Intervention Name(s)
Mock catheter
Intervention Description
Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle
Primary Outcome Measure Information:
Title
Anatomo-pathological changes of the endometrium after Lipiodol bathing
Description
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.
Time Frame
7 days after LH peak
Title
Histochemical changes of the endometrium after Lipiodol bathing
Description
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).
Time Frame
7 days after LH peak
Title
Transcriptional changes of the endometrium after Lipiodol bathing
Description
RNA sequencing
Time Frame
7 days after LH peak
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Blockeel, PhD
Phone
+3224776699
Email
christophe.blockeel@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie De Rijdt, MD
Email
sylvie.derijdt@uzbrussel.be
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Blockeel, PhD
Phone
+3224776699
Email
christophe.blockeel@uzbrussel.Be
First Name & Middle Initial & Last Name & Degree
Sylvie De Rijdt, MD
Email
sylvie.derijdt@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Christophe Blockeel, PhD
First Name & Middle Initial & Last Name & Degree
Annalisa Racca, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Endometrial Effects of Lipiodol
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