NCT03542331

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

April 13, 2018

Last Update Submit

May 3, 2019

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Control group

OTHER

The control group wille have a mock catheter introduction between day 6 and 8 of the cycle without any Lipiodol flush

Device: Mock catheter

Intervention group

EXPERIMENTAL

The intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle

Drug: Lipiodol

Interventions

LipiodolDRUG

Endometrial flushing with Lipiodol between day 6 and 8 of the cycle

Intervention group
Mock catheterDEVICE

Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle

Control group

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Ethiodized Oil

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Iodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Central Study Contacts

Christophe Blockeel, PhD

CONTACT

+3224776699christophe.blockeel@uzbrussel.be

Sylvie De Rijdt, MD

CONTACT

sylvie.derijdt@uzbrussel.be

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 31, 2018

Study Start

March 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations

BE(1)