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

Histological and Transcriptional Changes caused by Endometrial Flushing with Lipiodol: A Cross Over Study. - Changes at the level of the endometrium caused by Lipiodol intrauterine flush.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2017-004429-34-BE
Enrollment
20
Registered
2018-01-11
Start date
2018-02-15
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female subfertility MedDRA version: 20.0 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872

Interventions

Trade Name: Lipiodol Product Name: Lipiodol Pharmaceutical Form: Intrauterine solution

Sponsors

UZ Brussel
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Women aged =18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: We aimed to investigate whether the endometrial flushing with Lipiodol enhances fertility. We want to determine the anatomo-pathological, histochemical and transcriptional changes of the endometrium after Lipiodol bathing in a general population of healthy volunteers. ;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

MeasureTime frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

Countries

Belgium

Contacts

Public Contactstudy nurse

UZ Brussel CRG

3224776648

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026