Reproductive health Urological and Genital Diseases
Conditions
Interventions
All participants would be enrolled into one of two groups (Group 1: Days 7-14 of the menstrual cycle, Group 2: Days 15-22 of the menstrual cycle) and will have the device implanted for 7 days. From
Sponsors
Verso Biosense Limited
Eligibility
Sex/Gender
Female
Age
18 Years to 42 Years
Inclusion criteria
Inclusion criteria: 1. Women with unexplained infertility who have undergone at least one embryo transfer cycle after IVF without achieving a pregnancy. 2. Women who are at least 18 years of age and less than or equal to 42 years of age; 3. Clinically suitable for insertion of an intra-uterine device in an outpatient setting 4. No chronic illness e.g. diabetes, autoimmune disorders. 5. Patient able to comprehend and sign the Informed Consent prior to enrolment in the study. 6. BMI range 20 to 27 7. Able and willing to use barrier contraception (male condoms) or abstain from heterosexual intercourse during the menstrual cycle of the trial period. 8. Occurrence of one previous miscarriage is accepted.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding or planning a pregnancy during the course of the trial. 2. Currently taking an oral contraceptive or other hormone therapy 3. History of recurrent miscarriage. 4. Birth abnormalities or complications from previous pregnancies 5. Uterine anatomical abnormalities which, in the opinion of the investigator, may complicate placing and removal of the device. 6. Concomitant medical treatment for or has any significant disease or disorder which, in the opinion of the investigator, may put the participants at risk. 7. Known allergies to local anaesthetic, silicone and barium sulphate (both are components of the device) 8. Known allergy to or medical contraindication for sildenafil 9. Undergoing investigation for abnormal uterine bleeding. 10. Current pelvic inflammatory disease, cervicitis, current genital infection, conditions associated with increased susceptibility to infections, cervical dysplasia, uterine or cervical malignancy. 11. Concurrent use of body worn medical electronic devices. 12. No pre-existing or historical conditions which may impact on the outcomes of this study (e.g abnormal cx smear) 13. Planned overseas travel for the duration of the study 14. Unable to comply with the study protocol 15. Require X-ray’s or other medical scans for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the performance of the device measuring temperature and dissolved oxygen in the uterus during the mid-luteal phase before and after treatment with vaginal sildenafil in women who have failed to conceive after at least one completed IVF treatment. Quantitative data from the IRIS device will be collected across the 7 day study period. A post removal user experience questionnaire (study day 10/3 days post removal) will be conducted to collect qualitative data. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess reliability of the device in monitoring dissolved oxygen and temperature parameters. This will be measured by observing the baseline dissolved oxygen level range and change from baseline and 48 hours post Sildenafil administration. 2. Safety reporting by incidence of Adverse Events measured by use of medical notes in the case report forms, at all visits (study days 0, 2, 4, 6 and 7). 3. Brief Pain Inventory score measured using the visual analogue score (VAS) and recorded by patient in the patient diary across the 7 day study period as well as looking at clinical notes in the case reports forms (on study days 2, 4, 6 and 7). 4. Tolerance of the device and how much wearing the device interfered with patient ability to carry out activities will be measured by the patient and recorded in the patient diary across the 7 day study period. Tolerance of the device will be reported in the post removal user experience questionnaire (study day 10/3 days post removal). 5. Consumption of analgesics recorded by patient in the patient diary across the 7 day study period. 6. Patient retention will be measured by calculating the frequency of patients withdrawing and completing the study. | — |
Countries
England, United Kingdom
Contacts
Public ContactMariea Parvaz
Outcome results
None listed