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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uterine Lavage | Experimental | Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterine lavage | Procedure | embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI). |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Event Collection | Assessment of pain during procedure, bleeding experienced during procedure, and infection symptoms experienced subsequent to procedure. Assessment of fluid recovery, fluid loss through cervix, fluid accumulation in the uterus and fluid loss through fallopian tubes. | 30-Days |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of Embryos | 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). | 1 Day |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Nidal | Contact | 323-420-6343 | anidal@previvogenetics.com | |
| Gheda Sahyun, MA | Contact | 650-823-9093 | gsahyun@previvo.com |
| Name | Affiliation | Role |
|---|---|---|
| Gheda Sahyun, MA | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Punta Mita Hospital | Recruiting | Corral del Risco | Nayarit | 63734 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36988819 | Derived | Najmabadi S, Rivas JL, Angle MJ, Nadal A, Bastu E, Munne S, Carson SA, Buster JE, Nakajima ST. Human Uterine Lavage: First Live Births from In Vivo Conceived Genetically Screened Blastocysts. Adv Ther. 2023 May;40(5):2534-2541. doi: 10.1007/s12325-023-02486-1. Epub 2023 Mar 29. | |
| 31886877 | Derived | Munne S, Nakajima ST, Najmabadi S, Sauer MV, Angle MJ, Rivas JL, Mendieta LV, Macaso TM, Sawarkar S, Nadal A, Choudhary K, Nezhat C, Carson SA, Buster JE. First PGT-A using human in vivo blastocysts recovered by uterine lavage: comparison with matched IVF embryo controlsdagger. Hum Reprod. 2020 Jan 1;35(1):70-80. doi: 10.1093/humrep/dez242. |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D000091662 | Genital Diseases |
| D007246 | Infertility |