Infertility, Female Clinical Trial
Official title:
Controlled Ovarian Stimulation and Human Uterine Lavage: A Feasibility Study
This is a feasibility study intended to demonstrate the Previvo Uterine Lavage System's ability to recover embryos from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
The study is a prospective, multi- center, multiple-arm, feasibility study to evaluate the
safety and efficacy of the Previvo System in the recovery of embryos.
This study will recruit up to 500 healthy premenopausal volunteers. Subjects will undergo
either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian
hyperstimulation (COH)/intrauterine insemination (IUI) and have the lavage procedure
performed 4-6 days post IUI. It is anticipated that embryos recovered will be cryopreserved
for future use or donated for future use.
Subjects will be followed up with for up to 30 days after the lavage procedure. All data will
be collected on paper CRFs and analyzed by the Principal Investigator and Study Sponsor.
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