FemaSeed LOCAL Artificial Insemination Trial

NCT ID: NCT04968847

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Infertility Male Factor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, multi-center, single-arm
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device: FemaSeed Localized Directional Insemination

FemaSeed (Intratubal Insemination - K231730)

Group Type EXPERIMENTAL

FemaSeed Localized Directional Insemination

Intervention Type DEVICE

Subjects undergoing FemaSeed Artificial Insemination

Interventions

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FemaSeed Localized Directional Insemination

Subjects undergoing FemaSeed Artificial Insemination

Intervention Type DEVICE

Eligibility Criteria

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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)

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Femasys Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Elite IVF, PLLC

Mobile, Alabama, United States

Site Status

Reproductive Associates of Delaware (RAD Fertility)

Newark, Delaware, United States

Site Status

Women's Medical Research Group, LLC

Clearwater, Florida, United States

Site Status

Rosemark Women Care Specialists

Idaho Falls, Idaho, United States

Site Status

Saginaw Valley Medical Research Group

Saginaw, Michigan, United States

Site Status

The Fertility Center of Las Vegas

Las Vegas, Nevada, United States

Site Status

Red Rock Fertility Center

Las Vegas, Nevada, United States

Site Status

Reach Fertility

Charlotte, North Carolina, United States

Site Status

Carolina Conceptions

Raleigh, North Carolina, United States

Site Status

Institute for Reproductive Health

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Physicians

Cincinnati, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Main Line Fertility

Bryn Mawr, Pennsylvania, United States

Site Status

University of Pennsylvania (Pennsylvania Fertility Care)

Philadelphia, Pennsylvania, United States

Site Status

LinQ Research

Sugar Land, Texas, United States

Site Status

Center of Reproductive Medicine

Webster, Texas, United States

Site Status

Utah Center for Reproductive Medicine

Salt Lake City, Utah, United States

Site Status

University of Wisconsin, Generations Fertility Care

Middleton, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CP-200-001

Identifier Type: -

Identifier Source: org_study_id

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