Controlled Ovarian Stimulation and Human Uterine Lavage

August 28, 2019 updated by: Previvo Genetics

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Nayarit
      • Punta de Mita, Nayarit, Mexico, 63734
        • Recruiting
        • Punta Mita Hospital
        • Contact:
        • Principal Investigator:
          • Sam Najmabadi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30-Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Previvo Genetics

Investigators

  • Study Director: Gheda Sahyun, MA, Sponsor GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD-2104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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