Endometrial Effects of Lipiodol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

NCT00894946

Endometriosis In Vitro Fertilization Implantation Failure

UNKNOWN PHASE3

Endometrial Injury for Assisted Reproduction

NCT01132144

Infertility

TERMINATED PHASE3

Endometrial Sampling (Pipelle)in IVF Patients

NCT00411021

Infertility

UNKNOWN NA

A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)

NCT01533532

Endometriosis

COMPLETED PHASE2

Autologous Platelet-rich Plasma for Clomiphene Citrate-induced Thin Endometrium

NCT03770026

Infertility, Female, Associated With Anovulation

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Female Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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

Group Type OTHER

Mock catheter

Intervention Type DEVICE

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

Intervention group

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

Group Type EXPERIMENTAL

Lipiodol

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lipiodol

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

Intervention Type DRUG

Mock catheter

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes