Changes at the level of the endometrium caused by Lipiodol intrauterine flush.

Phase 1

• Conditions: Female subfertility; MedDRA version: 20.0 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-004429-34-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-11
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?known iodine allergy
?Body mass index ? 30 or =18.5
?Smoking
?Previous diagnosis of PCO (>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
?Received hormonal treatments in the previous 3 months
?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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: We aimed to investigate whether the endometrial flushing with Lipiodol enhances fertility.<br> We want to determine the anatomo-pathological, histochemical and transcriptional changes of the endometrium after Lipiodol bathing in a general population of healthy volunteers.<br><br> ;Secondary Objective: Not applicable;Primary end point(s): Anatomo-pathological, histochemical and transcriptional changes of the endometrium after Lipiodol bathing in a general population of healthy volunteers;Timepoint(s) of evaluation of this end point: All participants will be followed in two natural cycles. In each cycle an endometrial biopsy will be taken 7 days after the LH-surge. A wash out period of 3 months between the 2 biopsies will be respected.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable