Directional Artificial Insemination for Infertility

(LOCAL Trial)

Recruiting at 21 trial locations

Overseen By Study Director

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Femasys Inc.

Disqualifiers: More than 3 IUI cycles, recent pelvic infection, ectopic pregnancy history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

314 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new method called FemaSeed Localized Directional Insemination for artificial insemination. It aims to help individuals or couples who are trying to conceive by placing sperm in a specific location within the reproductive system. This targeted approach is designed to improve the chances of pregnancy.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment FemaSeed Localized Directional Insemination for infertility?

Research shows that concentrating motile sperm (sperm that can move well) through methods like density gradient centrifugation can improve pregnancy rates in artificial insemination, especially for certain infertility issues. This suggests that techniques focusing on optimizing sperm quality and delivery, similar to FemaSeed, may enhance the chances of conception. ^{1 2 3 4 5}

Is Directional Artificial Insemination generally safe for humans?

There is no specific safety data available for Directional Artificial Insemination or FemaSeed Localized Directional Insemination, but general safety concerns in assisted reproduction techniques include risks of multiple pregnancies, ovarian hyperstimulation syndrome, and potential congenital malformations, which are often related to the population studied rather than the techniques themselves. ^{6 7 8 9 10}

How is the FemaSeed Localized Directional Insemination treatment different from other infertility treatments?

FemaSeed Localized Directional Insemination is unique because it involves a targeted approach to insemination, potentially increasing the chances of fertilization by directing sperm more precisely to the egg, unlike traditional methods that rely on sperm finding the egg on their own. ^{1 3 11 12 13}

Eligibility Criteria

This trial is for couples facing male infertility, where the woman is aged 19-40 without tubal, uterine or ovarian issues and has at least one open fallopian tube. Men must have a certain sperm count after preparation. Participants can't have had more than three IUI cycles, past ectopic pregnancies or tubal surgeries, recent pelvic infections, or allergies to methotrexate.

Exclusion Criteria

I have not had a pelvic infection in the last 3 months.

Known allergy/sensitivity to methotrexate

I have undergone more than three IUI cycles.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FemaSeed Localized Directional Insemination procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for confirmed pregnancy and safety outcomes after the procedure

7 weeks

Treatment Details

Interventions

• FemaSeed Localized Directional Insemination

Trial Overview The FemaSeed Localized Directional Insemination technique is being tested for its safety and effectiveness in artificial insemination compared to standard procedures. The study aims to help couples with male factor infertility conceive.

Participant Groups

Group I: Device: FemaSeed Localized Directional Insemination Experimental Treatment 1 Intervention

FemaSeed (Intratubal Insemination - K231730)

Who Is Running the Clinical Trial?

Femasys Inc.

Lead Sponsor

Trials

6

Recruited

1,200+

Findings from Research

Assisted reproduction techniques (ART) have significantly improved the chances of conception for infertile couples, but the use of pharmacological agents in ART can lead to various adverse effects, including ovarian hyperstimulation syndrome and potential congenital malformations.

While gonadotropins are effective in stimulating ovarian function, they may be associated with risks such as luteal phase deficiency and concerns about long-term cancer risks, although these have not been conclusively proven.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of drugs used in assisted reproduction techniques. Al-Shawaf, T., Zosmer, A., Dirnfeld, M., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Advances in clinical micromanipulation of gametes and embryos. Assisted fertilization and hatching. [2005]

2. United States pubmed.ncbi.nlm.nih.gov

Practical evolution and application of direct intracytoplasmic sperm injection for male factor and idiopathic fertilization failure infertilities. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Improved semen qualities after continuous-step density gradient centrifugation: application to artificial insemination and pregnancy outcome. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Fallopian tube sperm perfusion: first clinical experience. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Management of male infertility by assisted reproductive technologies. [2007]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of drugs used in assisted reproduction techniques. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Intracytoplasmic sperm injection (ICSI)--what are the risks? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of recombinant human follicle-stimulating hormone in men with isolated hypogonadotropic hypogonadism. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Dose-response effects of estrogenic mycotoxins (zearalenone, alpha- and beta-zearalenol) on motility, hyperactivation and the acrosome reaction of stallion sperm. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Questions about the future of the child]. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of 225 patients undergoing subzonal insemination for the procurement of fertilization in vitro. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Subzonal insertion of multiple sperm is a treatment for male factor infertility. [2019]

13. China pubmed.ncbi.nlm.nih.gov

Pregnancies from subzonal insemination of unfertilized oocytes after conventional IVF. [2004]