Status:
UNKNOWN
Controlled Ovarian Stimulation and Human Uterine Lavage
Lead Sponsor:
Previvo Genetics
Conditions:
Infertility, Female
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
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), ...
Detailed 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 heal...
Eligibility Criteria
Inclusion
- Premenopausal female 18-40 years of age
- Physically healthy and reasonably healthy family medical history
- Having both ovaries with patent fallopian tubes, no known reproductive problems
- BMI between 18-35 Kg/m2
- Presence of a normal uterine cavity as assessed by sonohysterogram (SHG), hysterosalpingogram (HSG), or ultrasound
- Evidence of normal uterine anatomy that would not prevent the introduction of the lavage catheter.
Exclusion
- 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:
- Human immunodeficiency virus (HIV)
- Hepatitis B infection
- Hepatitis C infection
- Syphilis (RPR)
- Chlamydial pelvic infection
- Gonorrheal pelvic infection.
- Positive Pregnancy Test
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03426007
Start Date
September 1 2017
End Date
December 1 2019
Last Update
August 30 2019
Active Locations (1)
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1
Punta Mita Hospital
Punta de Mita, Nayarit, Mexico, 63734