Gamete biocompatibility of a paraben-free fertility lubricant

Abstract

Food and Drug Administration (FDA) created a new product code namely PEB, for the new class of fertility lubricants, which are gamete, fertilization and embryo compatible. To date, Baby Dance (BD) is the only FDA cleared fertility lubricant which is paraben free. The current study evaluates biocompatibility of a recently FDA cleared paraben-free lubricant (BD) on sperm motility and DNA fragmentation. Prospective studies to test the biocompatibility of BD on sperm motility, DNA fragmentation, and cervical mucus penetration. Sperm biocompatibility of BD (Fairhaven Health, Bellingham, WA) was evaluated as follows. 1) Unprocessed semen samples from normozoospermic (n = 10) and oligozoospermic (n = 10) men were incubated with human tubal fluid (HTF; Controls) or HTF plus 10% BD (Treated) for 30 min to determine sperm progressive motility (PM) according to WHO criteria and DNA fragmentation index (DFI) using the SCSA®. 2) Washed human sperm (normospermic men, n = 11) were incubated for 120 min. with or without 10% BD in HTF, followed by computer-assisted semen analysis (CASA) to evaluate Total Motile Sperm (TMS) counts . 3) Bovine cervical mucus assay was performed using cow mucus columns and bull sperm, to evaluate sperm penetration ability following 30 min incubation with or without 10% BD in Tris extender. Data is expressed as mean ± SD. 1) Sperm PM and DFI did not differ between treatments in either group. Normozoospermic: PM - Treated 72 ± 9% vs Control 73 ± 9%; DFI - Treated 8.8 ± 4.5% vs Control 9.0 ± 4.8%; Oligozoospermic: PM - Treated 62 ± 3% vs Control 63 ± 3%; DFI - Treated 10.6 ± 3.6% vs Control 10.6 ± 3.5%. 2) Numbers of TMS did not differ after exposure to BD (Treated TMS 11 ± 5 x 106/mL vs Control TMS 12 ± 4 x 106/mL). 3) Exposure to BD did not change sperm penetration into cervical mucus columns, although more sperm swam farther into columns following BD contact (Table 1). These studies suggest that the recently cleared PEB paraben-free fertility lubricant does not interfere with sperm function such as progressive sperm motility, DNA fragmentation and penetration ability in cervical mucus columns.Table 1Cervical mucus penetration of bull spermatozoa after exposure to 10% BDTreatmentNCASA Motility (%)Vanguard Sperm (cm)Sperm Density (2 cm)Sperm Density (3 cm)Control1040.0 ± 2.05.6 ± 0.227.9 ± 1.114.4 ± 0.9*BabyDance1042.0 ± 1.05.8 ± 0.229.7 ± 0.616.6 ± 0.6**Means differ between treatments at p=0.03 Open table in a new tab