Real time monitoring of the womb environment using a novel device

Not Applicable

• Conditions: Monitoring intrauterine parameters linked to fertilization; Pregnancy and Childbirth

• Registration Number: ISRCTN10654279
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-31
• Last Update Posted: 7 September 2021
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified