FemaSeed LOCAL Artificial Insemination Trial

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

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

Conditions
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Infertility, Male Factor

Intervention / Treatment
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* Device: FemaSeed Localized Directional Insemination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-center, single-arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FemaSeed<br>Investigational device and procedure | Device: FemaSeed Localized Directional Insemination<br>* Subjects undergoing FemaSeed Artificial Insemination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, IUI, Intrauterine Insemination, Unexplained, Male, Sperm