Natural ConceptionNCT05529160
FERTI-LILY Safety Study
An observational study of Natural Conception and Label Comprehension, run by Rosesta Medical BV at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Natural Conception, Label Comprehension, Device Usability
- What is being tested?
- FERTI LILY Conception Cup
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2022to 21 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who meet study eligibility criteria will be recruited from the patient population of the Principle Investigator's clinic.
Who may be able to join
- Subject is a female volunteer, age ≥ 18 years.
- Subject is willing and able to provide written informed consent for study participation.
- Subject agrees to use the FCC device as directed.
- Subject agrees to complete all study-related assessments.
- Subject agrees to try to use the cup within two weeks of disposition.
- PI confirms that the subject had the adequate label comprehension to enroll in the study.
Who cannot join
- Subject has a medical condition or other factor that, in the opinion of the investigator, would contraindicate participation in the study.
- Subject has active bacterial vaginosis infection or vaginismus.
- Subject has an abnormal clinically significant Pap Smear diagnosis.
- Subject has a history of endometriosis.
- Subject has any contraindications with the Instructions for Use.
- Subject has an allergy to silicone.
- Subject is pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boca Raton Obstetrics and Gynecology
Boca Raton, Florida, 33431
About this study
Official title: 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
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.
- Being tested
- FERTI LILY Conception Cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FERTI LILY Conception CupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Up to 20 subjects will be recruited from the patient population at the Principal Investigator's clinic. Subject recruitment will end once 15 evaluable subjects have completed the study. Receives: Device: FERTI LILY Conception Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Device
Occurrence of device-related adverse events.
Measured: 6 weeks
Secondary outcomes (2)
Label Comprehension Assessment Protocol
PI using questions and answers to assess comprehension and confirms subject can specify location and use of cup in vaginal model.
Measured: 6 weeks
Device Usability
After use reported by subject: ease of use, user compliance, overall satisfaction, comfort, size of device.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start29 Jul 2022
- Primary completion20 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural ConceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosesta Medical BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529160
- Sponsor's protocol ID
- FCC-001
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05529160
- Acronym / sponsor ID
- FCC-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rosesta Medical BVIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Device: FERTI LILY Conception CupUp to 20 subjects will be recruited from the patient population at the Principal Investigator's clinic. Subject recruitment will end once 15 evaluable subjects have completed the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who meet study eligibility criteria will be recruited from the patient population of the Principle Investigator's clinic.
Key inclusion criteria (6 listed)
- Subject is a female volunteer, age ≥ 18 years.
- Subject is willing and able to provide written informed consent for study participation.
- Subject agrees to use the FCC device as directed.
- Subject agrees to complete all study-related assessments.
- Subject agrees to try to use the cup within two weeks of disposition.
Key exclusion criteria (7 listed)
- Subject has a medical condition or other factor that, in the opinion of the investigator, would contraindicate participation in the study.
- Subject has active bacterial vaginosis infection or vaginismus.
- Subject has an abnormal clinically significant Pap Smear diagnosis.
- Subject has a history of endometriosis.
- Subject has any contraindications with the Instructions for Use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FERTI LILY Conception CupThe 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. | Device | Study Population |
Primary outcome
Safety of Device
Time frame: 6 weeks
Occurrence of device-related adverse events.
2 secondary outcomes
Label Comprehension Assessment Protocol
Time frame: 6 weeks
Device Usability
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
Related trials for Natural Conception
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruitingPhase 3
Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy
Diminished Ovarian Reserve (DOR), Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Natural Conception and Label Comprehension, run by Rosesta Medical BV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Device (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.