NOVEL

Is the sperm solution stable at room temperature for four hours?

  • Human Sperm Motility Bio Assay testing (HSSA) tests for the FDA 510(k) approval of EVIE consisted of sperm biocompatibility tests at 4, 6 and 24 hours at 32O
  • The sperm motility and morphology satisfied the HSSA criteria for sperm survivability and motility at these time points, when the sperm is prepared correctly in a suitable buffered medium in an andrology laboratory.

 

Is the sperm quality affected by being in the syringe and catheter system for four hours?

  • As the syringe and catheter are used for sperm delivery over four hours, each Lot is subjected to Human Sperm Motility Bio Assay testing (HSSA). They are non-toxic to human sperm, indicating that sperm has a forward progressive motility rate of equal to or more than ≥ 60% after 4 hours of contact (the FDA acceptable standard) with the product.

 

Why use saline instead of air to inflate the intrauterine catheter balloon?

  • Saline solution makes the balloon seat more firmly and securely against the internal cervical os.

 

Is there an advantage of using this method over double insemination procedure?

  • A 2003 Cochrane review1 found that performing two IUIs over consecutive days did not increase success rates.
  • In practice, two IUIs are costly in terms of time and money and is very inconvenient to the patient.
  • EVIE provides a convenient alternative to two IUIs with a better success rate.
  1. Cantineau et al. Single versus double intrauterine insemination (IUI) in stimulated cycles for subfertile couples.

Cochrane Database of Systematic Reviews 2003

 

Is there an increased potential risk of infection from using this method compared with standard IUI?

  • As with standard IUI, there may be a theoretical increased risk of ascending infection. The use of good aseptic technique may help reduce infection risk.
  • Prophylactic antibiotics may be considered as per institutional guidelines.

 

Does the patient have to stay in the clinic for 4 hours (or return to the clinic after 4 hours for catheter removal) or can the patient remove the catheter herself?

  • The device is approved for use by a qualified medical practitioner in a medical facility, but the patient may leave the clinic once the device has been activated.
  • In a clinical trial comparing slow release with bolus lUI, slow release study subjects were free to ambulate and bladder emptying was not restricted. However, the removal of the device can be carried out by the patient, as instructed by the clinician.

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