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Controlled Ovarian Stimulation and Human Uterine Lavage

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ClinicalTrials.gov Identifier: NCT03426007
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Infertility, Female Procedure: Uterine lavage Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Controlled Ovarian Stimulation and Human Uterine Lavage: A Feasibility Study
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Uterine Lavage
Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
Procedure: 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 :
  1. Serious Adverse Event Collection [ Time Frame: 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 :
  1. Recovery of Embryos [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426007


Contacts
Contact: Alex Nidal 323-420-6343 anidal@previvogenetics.com
Contact: Gheda Sahyun, MA 650-823-9093 gsahyun@previvo.com

Locations
Mexico
Punta Mita Hospital Recruiting
Punta de Mita, Nayarit, Mexico, 63734
Contact: Sam Najmabadi, MD    310-466-5132    najmabadi@reproductibe.org   
Principal Investigator: Sam Najmabadi, MD         
Sponsors and Collaborators
Previvo Genetics
Investigators
Study Director: Gheda Sahyun, MA Sponsor GmbH

Responsible Party: Previvo Genetics
ClinicalTrials.gov Identifier: NCT03426007     History of Changes
Other Study ID Numbers: TD-2104
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Previvo Genetics:
uterine lavage
intrauterine insemination
embryo
blastocyst
in vivo
superovulation

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female