InfertilityLOCALNCT04968847
FemaSeed LOCAL Artificial Insemination Trial
A study testing FemaSeed Localized Directional Insemination in people with Infertility and Male Factor, run by Femasys Inc. at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male Factor
- What is being tested?
- FemaSeed Localized Directional Insemination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 18 sitesUnited States
- Study dates
- 15 Jul 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Female, 19-40 years of age, with no tubal, uterine or ovarian infertility factor (including patent fallopian tubes with no evidence of hydrosalpinx)
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Main Line Fertility
Bryn Mawr, Pennsylvania, 19010
Reach Fertility
Charlotte, North Carolina, 28207
Institute for Reproductive Health
Cincinnati, Ohio, 45209
University of Cincinnati Physicians
Cincinnati, Ohio, 45229
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
The Fertility Center of Las Vegas
Las Vegas, Nevada, 89117
Red Rock Fertility Center
Las Vegas, Nevada, 89148
University of Wisconsin, Generations Fertility Care
Middleton, Wisconsin, 53562
Elite IVF, PLLC
Mobile, Alabama, 36608
Reproductive Associates of Delaware (RAD Fertility)
Newark, Delaware, 19713
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Pennsylvania (Pennsylvania Fertility Care)
Philadelphia, Pennsylvania, 19104
Carolina Conceptions
Raleigh, North Carolina, 27607
Saginaw Valley Medical Research Group
Saginaw, Michigan, 48604
Utah Center for Reproductive Medicine
Salt Lake City, Utah, 84108
LinQ Research
Sugar Land, Texas, 77479
Center of Reproductive Medicine
Webster, Texas, 77598
About this study
Official title: 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, now known as the FemaSeed Intratubal Insemination since FDA Cleared under K231730 in September 2023.
Read the detailed description
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
- Infertility, Male Factor
- Being tested
- FemaSeed Localized Directional Insemination
- Keywords
- Infertility, IUI, Intrauterine Insemination, Unexplained, Male, Sperm
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemaSeed Localized Directional InseminationDevice
Subjects undergoing FemaSeed Artificial Insemination
| Study group | Role | What they receive |
|---|---|---|
| Device: FemaSeed Localized Directional Insemination | Experimental | FemaSeed (Intratubal Insemination - K231730) Receives: Device: FemaSeed Localized Directional Insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start15 Jul 2021
- Primary completion31 Dec 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, single-arm
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Femasys Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968847
- Sponsor's protocol ID
- CP-200-001
- Acronym
- LOCAL
- Status last verified
- Nov 2024
- First submitted
- 9 Jul 2021
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination
- ClinicalTrials.gov ID
- NCT04968847
- Acronym / sponsor ID
- LOCAL / CP-200-001
- Conditions
- Infertility, Male Factor
- Keywords
- Infertility, IUI, Intrauterine Insemination, Unexplained, Male, Sperm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Femasys Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, single-arm
| Arm | Type | Receives |
|---|---|---|
| Device: FemaSeed Localized Directional Insemination | Experimental | Device: FemaSeed Localized Directional InseminationFemaSeed (Intratubal Insemination - K231730) |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Female, 19-40 years of age, with no tubal, uterine or ovarian infertility factor (including patent fallopian tubes with no evidence of hydrosalpinx)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemaSeed Localized Directional InseminationSubjects undergoing FemaSeed Artificial Insemination | Device | Device: FemaSeed Localized Directional Insemination |
Primary outcome
Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.
Time frame: 3 weeks
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
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 (based on current accepted clinical standards)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemaSeed Localized Directional Insemination in people with Infertility and Male Factor, run by Femasys Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure. (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.