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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).
Full description
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.
Enrollment
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Inclusion criteria
Exclusion criteria
History of, or presence of hydrosalpinx
Addiction to alcohol and/or narcotics
Had radiotherapy or chemotherapy
Existence of an ovarian cyst at the beginning of cycle with suspicion of malignancy or a large benign cyst
Contraindication for oral contraceptive pills or other study medication
Clinically significant abnormal basic metabolic panel lab results
Positive test or history of any of the following conditions:
Prior IUD for 60 days or less, or one currently in place
Allergic to study materials, supplies and medication
Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator
Primary purpose
Allocation
Interventional model
Masking
500 participants in 1 patient group
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Central trial contact
Gheda Sahyun, MA; Alex Nidal
Data sourced from clinicaltrials.gov
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