Béa Applicator and Béa Cervical Cap Safety and Usability Study

StepOne Fertility

Status: Unknown

Conditions: Safety and Usability

Treatments: Device: Béa Applicator and Béa Cervical Cap Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129553

SOF63073301

Details and patient eligibility

About

This is a Clinical Study Designed to Validate the Usability and Safety of the Over-the-counter (OTC) Béa Applicator and Béa Cervical Cap Device in a Home Use Environment.

Full description

Female participants will undergo a baseline physical assessment performed by a physician at the study site. The participants will then be given the Béa Applicator and Béa Cervical Cap device with accompanying instructions and a semen collection pot. The participants will return home to use the device as per the Instruction for Use (IFU). The Béa Cervical Cap will remain in place for a minimum of 4 hours and a maximum of 6 hours. At the follow-up assessment, the investigator will investigate all primary objectives via a physical exam or via questioning the participant.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• People who are able to and for whom it is medically safe to conceive
• Heterosexual couples and individuals, of any race or ethnicity, who are sexually active
• 18 - 40 years of age
• Trying to conceive
• Signed Informed Consent
• Approximately nineteen per cent (19%) of participants will present with a retroverted uterus as found in the general female population.

Exclusion criteria

• Vaginal prolapse (female)
• Hysterectomy (female)
• Erectile dysfunction (male)
• Diagnosis and/or treatment of vaginitis or sexually transmitted infection (STI) within the last month
• Colposcopy with biopsy surgery within the last three (3) months (female)
• Treatment for dysplasia surgery within the previous three (3) months (female)
• Vaginal/cervical surgery within the last three (3) months (female)
• Current pregnancy (female)
• Unable to read and understand English, as assessed by REALM
• Presence of noticeable lesions, open sores, viral warts, and any other genital abnormalities (female & male)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Single Use

Experimental group

Description:

The participants will then be given the Béa Applicator and Béa Cervical Cap with accompanying instructions for single-use in a home use environment.

Treatment:

Device: Béa Applicator and Béa Cervical Cap Device