EUCTR2017-004429-34-BE
Active, not recruiting
Phase 1
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.
Z Brussel0 sites20 target enrollmentJanuary 11, 2018
ConditionsFemale subfertilityMedDRA version: 20.0 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsLipiodol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Female subfertility
- Sponsor
- Z Brussel
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •?known iodine allergy
- •?Body mass index ? 30 or \=18\.5
- •?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
Outcomes
Primary Outcomes
Not specified
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