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).
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Premenopausal female 18-40 years of age 2. Physically healthy and reasonably healthy family medical history 3. Having both ovaries with patent fallopian tubes, no known reproductive problems 4. BMI between 18-35 Kg/m2 5. Presence of a normal uterine cavity as assessed by sonohysterogram (SHG), hysterosalpingogram (HSG), or ultrasound 6. Evidence of normal uterine anatomy that would not prevent the introduction of the lavage catheter. Exclusion Criteria: 1. History of, or presence of hydrosalpinx 2. Addiction to alcohol and/or narcotics 3. Had radiotherapy or chemotherapy 4. Existence of an ovarian cyst at the beginning of cycle with suspicion of malignancy or a large benign cyst 5. Contraindication for oral contraceptive pills or other study medication 6. Clinically significant abnormal basic metabolic panel lab results 7. Positive test or history of any of the following conditions: 1. Human immunodeficiency virus (HIV) 2. Hepatitis B infection 3. Hepatitis C infection 4. Syphilis (RPR) 5. Chlamydial pelvic infection 6. Gonorrheal pelvic infection. 7. Positive Pregnancy Test 8. Prior IUD for 60 days or less, or one currently in place 9. Allergic to study materials, supplies and medication 10. Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator |
Country | Name | City | State |
---|---|---|---|
Mexico | Punta Mita Hospital | Punta de Mita | Nayarit |
Lead Sponsor | Collaborator |
---|---|
Previvo Genetics |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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