Monitoring intrauterine parameters linked to fertilization Pregnancy and Childbirth
Conditions
Interventions
The study will use the IRIS System to investigate the feasibility to recruit to a study to investigate the biophysical profile of dissolved oxygen (DO), pH, and temperature within the uterus of women
Sponsors
University of Southampton
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women recruited from the subfertility/gynaecology outpatients clinic with or without reproductive disorders 2. Aged between 18 and 42 years inclusive 3. Clinically suitable for insertion of device in outpatients 4. No chronic illness that influences fertility (such as diabetes or autoimmune disorders) 5. Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study 6. BMI <35 7. Able and willing to use barrier contraception or abstain from sexual intercourse in the menstrual cycle of the trial period
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating, or planning pregnancy during the course of the trial 2. Hormonal treatment 3. Any concomitant medical treatment for or has any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 4. Allergy to anaesthetics (where applicable), silicone, or barium sulphate 5. Current ongoing investigations of abnormal uterine bleeding 6. Current, ongoing, or recurrent vaginal or pelvic infection 7. Body-worn life-sustaining electronic devices. 8. Abnormalities within the reproductive tract prohibiting the safe insertion of an intrauterine device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical feasibility measured using the following: 1.1. Rate of recruitment and retention of participants from Investigator's notes between baseline and 10 days 1.2. Ease of device insertion measured at baseline, carriage for up to 7 days measured between baseline and 7 days, and ease of removal measured at 7 days 1.3. Use of the device in women with a spectrum of endometrial receptivity recorded at nurse telephone follow-up at 1, 3, 5, 7, and 10 days 2. Safety measured using the incidence of any device-related AEs that are within the acceptable limits defined by Vivoplex’s Risk Management File recorded at nurse telephone follow-up at 1, 3, 5, 7, and 10 days 3. Technical feasibility measured as the rate of successful temperature, pH, and dissolved oxygen data capture based on the schedule of data transmission of the device between baseline and 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical safety measured from the presence or report of the following clinical side effects/adverse events between baseline and 10 days: 1.1. Evidence of clinically confirmed or suspected uterine/pelvic infection 1.2. Pelvic pain at or after insertion 1.3. Irregular vaginal bleeding 1.4. Device expulsion or perforation 2. Device usability measured from device-related AEs associated with use-error between baseline and 10 days 3. Technical safety measured using body temperature between baseline and 7 days | — |
Countries
England, United Kingdom
Outcome results
None listed