Female InfertilityPhase 3NCT03542331
Endometrial Effects of Lipiodol
A Phase 3 study testing Lipiodol and Mock catheter in people with Female Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility
- What is being tested?
- Lipiodol and Mock catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2018to Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sylvie De Rijdt, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Christophe Blockeel, PhD, +3224776699, christophe.blockeel@uzbrussel.Be
Sylvie De Rijdt, MD, sylvie.derijdt@uzbrussel.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Female Infertility
- Being tested
- Lipiodol, Mock catheter
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipiodolDrug
Endometrial flushing with Lipiodol between day 6 and 8 of the cycle
Mock catheterDevice
Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The control group wille have a mock catheter introduction between day 6 and 8 of the cycle without any Lipiodol flush Receives: Device: Mock catheter |
| Intervention group | Experimental | The intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle Receives: Drug: Lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 7 days after LH peak
Transcriptional changes of the endometrium after Lipiodol bathing
RNA sequencing
Measured: 7 days after LH peak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Mar 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542331
- Sponsor's protocol ID
- 2017.lipiodol.flush
- Status last verified
- May 2019
- First submitted
- 13 Apr 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Transcriptional Changes Caused by Endometrial Flushing With Lipiodol: A Cross Over Study
- ClinicalTrials.gov ID
- NCT03542331
- Acronym / sponsor ID
- 2017.lipiodol.flush
- Conditions
- Female Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Device: Mock catheterThe control group wille have a mock catheter introduction between day 6 and 8 of the cycle without any Lipiodol flush |
| Intervention group | Experimental | Drug: LipiodolThe intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipiodolEndometrial flushing with Lipiodol between day 6 and 8 of the cycle | Drug | Intervention group |
| Mock catheterIntroduction of a mock catheter in the uterus between day 6 and 8 of the cycle | Device | Control group |
Primary outcome
Anatomo-pathological changes of the endometrium after Lipiodol bathing
Time frame: 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
Time frame: 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
Time frame: 7 days after LH peak
RNA sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie De Rijdt, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lipiodol and Mock catheter in people with Female Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Blockeel, PhD (+3224776699, christophe.blockeel@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomo-pathological changes of the endometrium after Lipiodol bathing (time frame: 7 days after LH peak). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.