Controlled Ovarian Stimulation and Human Uterine Lavage

Not Applicable

• Conditions: Infertility, Female
• Interventions: Procedure: Uterine lavage

• Registration Number: NCT03426007
• Lead Sponsor: Previvo Genetics

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Uterine Lavage	Uterine lavage	Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).

Primary Outcome Measures

Name	Time	Method
Serious Adverse Event Collection	30-Days	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.

Secondary Outcome Measures

Name	Time	Method
Recovery of Embryos	1 Day	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).

Trial Locations

Locations (1)

Punta Mita Hospital; 🇲🇽 Punta de Mita, Nayarit, Mexico