Controlled Ovarian Stimulation and Human Uterine Lavage

Study Overview
=================
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), or controlled ovarian hyperstimulation (COH)/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 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.

Official Title
-----------------
Controlled Ovarian Stimulation and Human Uterine Lavage: A Feasibility Study

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Procedure: Uterine lavage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterine Lavage<br>Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI). | Procedure: Uterine lavage<br>* embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterine lavage, intrauterine insemination, embryo, blastocyst, in vivo, superovulation