Female subfertility MedDRA version: 20.0 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
UZ Brussel CRG