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FemaSeed LOCAL Artificial Insemination Trial (LOCAL)

Primary Purpose

Infertility, Male Factor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FemaSeed Localized Directional Insemination
Sponsored by
Femasys Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, IUI, Intrauterine Insemination, Unexplained, Male, Sperm

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Elite IVF, PLLCRecruiting
  • Reproductive Associates of Delaware (RAD Fertility)Recruiting
  • Women's Medical Research Group, LLCRecruiting
  • Rosemark Women Care SpecialistsRecruiting
  • Saginaw Valley Medical Research GroupRecruiting
  • The Fertility Center of Las VegasRecruiting
  • Red Rock Fertility CenterRecruiting
  • Reach FertilityRecruiting
  • Carolina ConceptionsRecruiting
  • Institute for Reproductive HealthRecruiting
  • University of Cincinnati PhysiciansRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Main Line FertilityRecruiting
  • University of Pennsylvania (Pennsylvania Fertility Care)Recruiting
  • LinQ ResearchRecruiting
  • Center of Reproductive MedicineRecruiting
  • Utah Center for Reproductive MedicineRecruiting
  • University of Wisconsin, Generations Fertility CareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FemaSeed

Arm Description

Investigational device and procedure

Outcomes

Primary Outcome Measures

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.
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)
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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2021
Last Updated
September 21, 2023
Sponsor
Femasys Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04968847
Brief Title
FemaSeed LOCAL Artificial Insemination Trial
Acronym
LOCAL
Official Title
LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Femasys Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male Factor
Keywords
Infertility, IUI, Intrauterine Insemination, Unexplained, Male, Sperm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multi-center, single-arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FemaSeed
Arm Type
Experimental
Arm Description
Investigational device and procedure
Intervention Type
Device
Intervention Name(s)
FemaSeed Localized Directional Insemination
Intervention Description
Subjects undergoing FemaSeed Artificial Insemination
Primary Outcome Measure Information:
Title
Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.
Description
Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy.
Time Frame
3 weeks
Title
Primary Safety: Occurrence of ectopic pregnancy per cycle
Description
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)
Time Frame
7 weeks
Title
Primary Safety: Occurrence of uterine perforation per cycle
Description
Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation.
Time Frame
At time of procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) Couples who have documented male factor infertility, total motile sperm count of ≥1 million and ≤ 20 million post sperm preparation 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: 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 Known allergy/ sensitivity to methotrexate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
700-500-3910
Ext
146
Email
FemaSeedSupport@femasys.com
Facility Information:
Facility Name
Elite IVF, PLLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
251-490-5759
Facility Name
Reproductive Associates of Delaware (RAD Fertility)
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
302-602-8852
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
727-724-9730
Facility Name
Rosemark Women Care Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
208-557-2982
Facility Name
Saginaw Valley Medical Research Group
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
989-497-5851
Facility Name
The Fertility Center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
702-254-1777
Facility Name
Red Rock Fertility Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
702-262-0079
Ext
123
Facility Name
Reach Fertility
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
704-343-4455
Facility Name
Carolina Conceptions
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
919-782-5911
Facility Name
Institute for Reproductive Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
513-924-5577
Facility Name
University of Cincinnati Physicians
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
513-584-4509
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
405-271-1616
Facility Name
Main Line Fertility
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
484-380-4861
Facility Name
University of Pennsylvania (Pennsylvania Fertility Care)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
215-615-5162
Facility Name
LinQ Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
281-916-4220
Facility Name
Center of Reproductive Medicine
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
281-557-3084
Facility Name
Utah Center for Reproductive Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
801-581-8425
Facility Name
University of Wisconsin, Generations Fertility Care
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
608-820-3293

12. IPD Sharing Statement

Plan to Share IPD
No

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FemaSeed LOCAL Artificial Insemination Trial

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