FemaSeed LOCAL Artificial Insemination Trial

Infertility Clinical Trial

— LOCAL  

Official title:

LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04968847
• Other study ID #: CP-200-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Femasys Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of the trial are to evaluate the safety and effectiveness of the FemaSeed Localized Directional Insemination for artificial insemination.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: April 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Female, 19-40 years of age, with no tubal, uterine or ovarian infertility factor (including patent fallopian tubes with no evidence of hydrosalpinx)

2. Couples who have documented male factor infertility, total motile sperm count of =1 million and = 20 million post sperm preparation

3. Agrees to receive medical treatment with methotrexate if diagnosed during the course of the study with an ectopic pregnancy and meets the clinical criteria for medical management (i.e., hemodynamically stable, unruptured mass and no absolute contraindications to methotrexate administration)

Exclusion Criteria:

1. Greater than three prior intrauterine insemination (IUI) cycles

2. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes)

3. Prior history of ectopic pregnancy or tubal surgery

4. Known allergy/ sensitivity to methotrexate

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• FemaSeed Localized Directional Insemination
Subjects undergoing FemaSeed Artificial Insemination

Locations

Country	Name	City	State
United States	Main Line Fertility	Bryn Mawr	Pennsylvania
United States	Reach Fertility	Charlotte	North Carolina
United States	Institute for Reproductive Health	Cincinnati	Ohio
United States	University of Cincinnati Physicians	Cincinnati	Ohio
United States	Women's Medical Research Group, LLC	Clearwater	Florida
United States	Rosemark Women Care Specialists	Idaho Falls	Idaho
United States	Red Rock Fertility Center	Las Vegas	Nevada
United States	The Fertility Center of Las Vegas	Las Vegas	Nevada
United States	University of Wisconsin, Generations Fertility Care	Middleton	Wisconsin
United States	Elite IVF, PLLC	Mobile	Alabama
United States	Reproductive Associates of Delaware (RAD Fertility)	Newark	Delaware
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Pennsylvania (Pennsylvania Fertility Care)	Philadelphia	Pennsylvania
United States	Carolina Conceptions	Raleigh	North Carolina
United States	Saginaw Valley Medical Research Group	Saginaw	Michigan
United States	Utah Center for Reproductive Medicine	Salt Lake City	Utah
United States	LinQ Research	Sugar Land	Texas
United States	Center of Reproductive Medicine	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Femasys Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.	Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy.	3 weeks
Primary	Primary Safety: Occurrence of ectopic pregnancy per cycle	Occurrence of ectopic pregnancy per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in a definitively confirmed ectopic pregnancy (based on current accepted clinical standards)	7 weeks
Primary	Primary Safety: Occurrence of uterine perforation per cycle	Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation.	At time of procedure