NCT03542331

Endometrial Effects of Lipiodol

Histological and Transcriptional Changes Caused by Endometrial Flushing With Lipiodol: A Cross Over Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Accepted

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.

Conditions

• Female Infertility

Interventions

Type	Name	Description
DRUG	Lipiodol	Endometrial flushing with Lipiodol between day 6 and 8 of the cycle
DEVICE	Mock catheter	Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2018-05-31
• Last updated: 2019-05-06

Locations

1 site across 1 country: Belgium