Controlled Ovarian Stimulation and Human Uterine Lavage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Infertility, Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Uterine Lavage

Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).

Group Type EXPERIMENTAL

Uterine lavage

Intervention Type PROCEDURE

embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).

Interventions

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Uterine lavage

embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes