NCT04968847

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

July 9, 2021

Last Update Submit

November 7, 2024

Conditions

InfertilityMale Factor

Keywords

InfertilityIUIIntrauterine InseminationUnexplainedMaleSperm

Outcome Measures

Primary Outcomes (3)

  • 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 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 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

Study Arms (1)

Device: FemaSeed Localized Directional Insemination

EXPERIMENTAL

FemaSeed (Intratubal Insemination - K231730)

Device: FemaSeed Localized Directional Insemination

Interventions

FemaSeed Localized Directional InseminationDEVICE

Subjects undergoing FemaSeed Artificial Insemination

Device: FemaSeed Localized Directional Insemination

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Elite IVF, PLLC

Mobile, Alabama, 36608, United States

Location

Reproductive Associates of Delaware (RAD Fertility)

Newark, Delaware, 19713, United States

Location

Women's Medical Research Group, LLC

Clearwater, Florida, 33759, United States

Location

Rosemark Women Care Specialists

Idaho Falls, Idaho, 83404, United States

Location

Saginaw Valley Medical Research Group

Saginaw, Michigan, 48604, United States

Location

The Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

Location

Red Rock Fertility Center

Las Vegas, Nevada, 89148, United States

Location

Reach Fertility

Charlotte, North Carolina, 28207, United States

Location

Carolina Conceptions

Raleigh, North Carolina, 27607, United States

Location

Institute for Reproductive Health

Cincinnati, Ohio, 45209, United States

Location

University of Cincinnati Physicians

Cincinnati, Ohio, 45229, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Main Line Fertility

Bryn Mawr, Pennsylvania, 19010, United States

Location

University of Pennsylvania (Pennsylvania Fertility Care)

Philadelphia, Pennsylvania, 19104, United States

Location

LinQ Research

Sugar Land, Texas, 77479, United States

Location

Center of Reproductive Medicine

Webster, Texas, 77598, United States

Location

Utah Center for Reproductive Medicine

Salt Lake City, Utah, 84108, United States

Location

University of Wisconsin, Generations Fertility Care

Middleton, Wisconsin, 53562, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, multi-center, single-arm
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 20, 2021

Study Start

July 15, 2021

Primary Completion

December 31, 2023

Study Completion

April 30, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(18)