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出境医 / 临床实验 / FemaSeed LOCAL Artificial Insemination Trial (LOCAL)

FemaSeed LOCAL Artificial Insemination Trial (LOCAL)

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.

Condition or disease Intervention/treatment Phase
Infertility Device: FemaSeed Localized Directional Insemination Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 792 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, Multi-center, international, single-arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: FemaSeed
Investigational device and procedure
 Device: FemaSeed Localized Directional Insemination
Subjects undergoing FemaSeed Artificial Insemination
Outcome Measures
Primary Outcome Measures :
  1. Primary Effectiveness: Confirmed clinical pregnancy with fetal heartbeat rate [ Time Frame: 7 weeks ]
    Confirmed clinical pregnancy with fetal heartbeat rate per cycle defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in clinical pregnancy with fetal heartbeat.

  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.

  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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female, 19-40 years of age, and infertile
  2. Meets qualifications for standard intrauterine insemination procedure
  3. At least one patent fallopian tube with no evidence of hydrosalpinx

Exclusion Criteria:

  1. Greater than three prior intrauterine insemination (IUI) cycles or any prior assisted reproduction procedure (e.g. IVF)
  2. Current or recent pelvic infection
  3. Prior ectopic pregnancy or tubal surgery other than salpingectomy
Contacts and Locations

Contacts
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Contact: Study Director 700-500-3910 ext 146 FemaSeedSupport@femasys.com

Locations
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United States, Florida
Women's Medical Research Group, LLC Recruiting
Clearwater, Florida, United States, 33759
Contact: Research Coordinator    727-724-9730      
United States, Michigan
Saginaw Valley Medical Research Group Recruiting
Saginaw, Michigan, United States, 48604
Contact: Research Coordinator    989-497-5851      
United States, Nevada
Red Rock Fertility Center Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Research Coordinator    702-262-0079 ext 123      
United States, North Carolina
Carolina Conceptions Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Research Coordinator         
United States, Ohio
University of Cincinnati Physicians Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Research Coordinator    513-584-4509      
United States, Pennsylvania
Main Line Fertility Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Research Coordinator    484-380-4861      
Sponsors and Collaborators
Femasys Inc.
Tracking Information
First Submitted Date  ICMJE July 9, 2021
First Posted Date  ICMJE July 20, 2021
Last Update Posted Date December 1, 2021
Actual Study Start Date  ICMJE July 15, 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • Primary Effectiveness: Confirmed clinical pregnancy with fetal heartbeat rate [ Time Frame: 7 weeks ]
    Confirmed clinical pregnancy with fetal heartbeat rate per cycle defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in clinical pregnancy with fetal heartbeat.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2021)
  • Primary Effectiveness [ Time Frame: 7 weeks ]
    Confirmed clinical pregnancy with fetal heartbeat rate post FemaSeed procedure
  • Primary Safety [ Time Frame: 7 weeks ]
    Occurrence of ectopic pregnancy per cycle
  • Primary Safety [ Time Frame: At time of procedure ]
    Occurrence of uterine perforation per cycle
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FemaSeed LOCAL Artificial Insemination Trial
Official Title  ICMJE LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination
Brief Summary The objectives of the trial are to evaluate the safety and effectiveness of the FemaSeed Localized Directional Insemination for artificial insemination.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, Multi-center, international, single-arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE Device: FemaSeed Localized Directional Insemination
Subjects undergoing FemaSeed Artificial Insemination
Study Arms  ICMJE Experimental: FemaSeed
Investigational device and procedure
Intervention: Device: FemaSeed Localized Directional Insemination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2021) 		792
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female, 19-40 years of age, and infertile
  2. Meets qualifications for standard intrauterine insemination procedure
  3. At least one patent fallopian tube with no evidence of hydrosalpinx

Exclusion Criteria:

  1. Greater than three prior intrauterine insemination (IUI) cycles or any prior assisted reproduction procedure (e.g. IVF)
  2. Current or recent pelvic infection
  3. Prior ectopic pregnancy or tubal surgery other than salpingectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Study Director 700-500-3910 ext 146 FemaSeedSupport@femasys.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04968847
Other Study ID Numbers  ICMJE CP-200-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Femasys Inc.
Study Sponsor  ICMJE Femasys Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Femasys Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP