Skip to main content
OpenTrials
Completed

NCT Number: NCT04968847

FemaSeed LOCAL Artificial Insemination Trial

Brief Summary: The objectives of the trial are to evaluate the safety and effectiveness of the FemaSeed Localized Directional Insemination for artificial insemination, now known as the FemaSeed Intratubal Insemination since FDA Cleared under K231730 in September 2023.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Genital Diseases Male Factor Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Elite IVF, PLLC, Mobile, Alabama, United States

Loading trial locations.

About this study

314 subjects enrolled (signed inform consent) inclusive of 188 subjects in protocol versions 1-4 and 126 subjects in protocol version 5 (including re-consented subjects).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Greater than three prior intrauterine insemination (IUI) cycles
  • Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes)
  • Prior history of ectopic pregnancy or tubal surgery

Treatment and study plan

FemaSeed Localized Directional Insemination

Device

Subjects undergoing FemaSeed Artificial Insemination

Primary outcomes

  1. Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.

    Time frame: 3 weeks

    Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy.

  2. Primary Safety: Occurrence of ectopic pregnancy per cycle

    Time frame: 7 weeks

    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)

  3. Primary Safety: Occurrence of uterine perforation per cycle

    Time frame: At time of procedure

    Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation.

Sponsors and collaborators

Lead sponsor

Femasys Inc.

Industry

Registry information

Official study title

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

Acronym: LOCAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 20, 2021
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.