Positive data from trial of FemaSeed infertility treatment

Positive data has been reported from a pivotal trial of the infertility treatment FemaSeed intratubal insemination (ITI) – a type of artificial insemination designed to enhance fertilisation by precisely delivering sperm into the fallopian tube, the natural site of conception.

FemaSeed, developed by biomedical company Femasys, was shown in the study to be a safe and effective treatment option to achieve pregnancy in couples with male-factor or unexplained infertility and low male sperm count.

The publication includes positive data from the pivotal trial which met its primary endpoint with a pregnancy rate per subject of 26.3 per cent and 17.5 per cent per cycle, which was significantly higher than the performance goal of 7 per cent based on the historical control.

Safety reports were consistent with IUI. The vast majority of subjects stated they would probably or definitely recommend FemaSeed, and investigator satisfaction was similarly high.

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 catheterisation likely increases sperm-oocyte interaction, suggestive of improved efficiency over conventional intrauterine insemination particularly for male-factor infertility.

Kathy Lee-Sepsick, CEO of Femasys, commented: “Our impressive pivotal data for FemaSeed, showed significantly improved pregnancy rates, over double that of intrauterine insemination (IUI) for low male sperm count, a primary or contributing cause of infertility for approximately 50 per cent of couples.

“FemaSeed offers a highly effective, first-line solution for women and couples seeking a less invasive and more affordable option than in vitro fertilization (IVF).”