NCT03426007

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

January 29, 2018

Last Update Submit

August 28, 2019

Conditions

Infertility, Female

Keywords

uterine lavageintrauterine inseminationembryoblastocystin vivosuperovulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Recovery of Embryos

    1 Day

Study Arms (1)

Uterine Lavage

EXPERIMENTAL

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

Procedure: Uterine lavage

Interventions

Uterine lavagePROCEDURE

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

Uterine Lavage

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Punta Mita Hospital

Punta de Mita, Nayarit, 63734, Mexico

RECRUITING

Related Publications (2)

  • Najmabadi S, Rivas JL, Angle MJ, Nadal A, Bastu E, Munne S, Carson SA, Buster JE, Nakajima ST. Human Uterine Lavage: First Live Births from In Vivo Conceived Genetically Screened Blastocysts. Adv Ther. 2023 May;40(5):2534-2541. doi: 10.1007/s12325-023-02486-1. Epub 2023 Mar 29.

    PMID: 36988819DERIVED

  • Munne S, Nakajima ST, Najmabadi S, Sauer MV, Angle MJ, Rivas JL, Mendieta LV, Macaso TM, Sawarkar S, Nadal A, Choudhary K, Nezhat C, Carson SA, Buster JE. First PGT-A using human in vivo blastocysts recovered by uterine lavage: comparison with matched IVF embryo controlsdagger. Hum Reprod. 2020 Jan 1;35(1):70-80. doi: 10.1093/humrep/dez242.

    PMID: 31886877DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Gheda Sahyun, MA

    Sponsor GmbH

    STUDY DIRECTOR

Central Study Contacts

Alex Nidal

CONTACT

323-420-6343anidal@previvogenetics.com

Gheda Sahyun, MA

CONTACT

650-823-9093gsahyun@previvo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 8, 2018

Study Start

September 1, 2017

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)