Journal of Gynecology & Reproductive Medicine(JGRM)
ISSN: 2576-2842 | DOI: 10.33140/JGRM
Impact Factor: 1.247
FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count
Abstract
James H. Liu, Michael Glassner, Clarisa R. Gracia, Erica B. Johnstone, Vicki L. Schnell, Michael A. Thomas, Leavitt Morrison and Kathy Lee-Sepsick
Objective: To report pregnancy outcomes following intratubal insemination without catheterization using the FemaSeed device in a population of low sperm count couples.
Methods: A prospective, single-arm, historical control, pivotal trial (Clinicaltrials.gov NCT04968847) of females aged 19-40 years with male-factor or unexplained infertility and total motile sperm count of 1-20 million undergoing intratubal insemination (ITI) with the FemaSeed device, conducted at twelve academic and private medical centers in the USA. Pregnancy was confirmed at 3 weeks (-7 days) by serum β-hCG and follow-up continued at 7 weeks (±7 days) for safety, including pregnancy test by serum β-hCG and ultrasonography.
Results: The pregnancy rate for ITI with FemaSeed per subject was 26.3% (95%CI: 13.4â??43.1%; n=10/38) and 17.5% per cycle (95%LCB: 7.6%, 95%CI: 5.7â??29.4%; n=10/57), which was significantly higher than the performance goal of 7% based on the historical control (one-sided P=0.041). The cumulative pregnancy rates through the first and second ITI cycles were 15.8% (95%CI: 7.4â??31.8%) and 30.7% (95%CI: 16.5â??52.5%), respectively. Safety reports were consistent with intrauterine insemination (IUI), of note ectopic pregnancy and uterine perforation occurred in 0.5% (95%CI: <0.05â??2.5%; n=1/222) and 0.0% of cycles, respectively.
Conclusion: Targeted intratubal insemination of washed spermatozoa using the FemaSeed ITI device is a safe artificial insemination technique that demonstrated high effectiveness for couples with male-factor/unexplained infertility associated with low male sperm count. Delivery of washed spermatozoa directly into the utero-tubal ostium and fallopian tube without catheterization likely increases sperm-oocyte interaction, suggestive of improved efficiency over conventional intrauterine insemination particularly for male-factor infertility.