NCT05529160

FERTI-LILY Safety Study

A Prospective, 1-Arm, Open Label, Non-Randomized Study of the FERTI-LILY Conception Cup Device to Assess Label Comprehension, Device Usability and Safety in Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Rosesta Medical BV · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study is a prospective, 1-arm, open label, nonrandomized, single center study designed to evaluate label comprehension, device usability and safety of the FERTI·LILY Conception Cup. The primary safety endpoint will be an assessment of reported adverse events. Subjects will be screened -10 (±3) days prior to the baseline visit. At baseline, 15-20 subjects meeting the inclusion/exclusion criteria will be provided with a FERTI·LILY Conception Cup device and instructions for using the device. Subjects will participate in a label comprehension protocol that includes the physician confirmation that they have adequate comprehension to enroll. If not, a screen failure form is completed. Subjects will agree to try and use the device within 2 weeks of disposition therefore at baseline a two-week visit is scheduled. In the event they do not use the device within the two-week period the follow up visit can be rescheduled based on the visit window of +14 days. If it is not used within 4 weeks, the PI will have the subject return to the site to authorize another two-week period that will be captured as unscheduled follow up visit. The subject should complete the Device Experience Survey after each device use. The Device Experience Survey will be returned at this time, and adverse events will be assessed.

Conditions

• Natural Conception
• Label Comprehension
• Device Usability
• Safety Issues

Interventions

Type	Name	Description
DEVICE	FERTI LILY Conception Cup	The FERTI-LILY Conception Cup is indicated for over-the-counter (OTC) home use by couples trying to conceive. The FERTI·LILY device OTC contains a cervical cap attached to a stem. The FERTI-LILY Conception Cup is intended to push semen towards the cervix as an aid in conception. It is designed to be inserted vaginally after intercourse and left in place for 20-60 minutes. The device is recommended to be used during the ovulatory phase of the menstrual cycle. It is not to be left in place for longer than six hours. The device may be re-used up to 18 times or over 6 cycles.

Timeline

• Start date: 2022-07-29
• Primary completion: 2022-09-20
• Completion: 2022-09-21
• First posted: 2022-09-06
• Last updated: 2023-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study