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Status unknownNCT03426007Updated Aug 30, 2019

Controlled Ovarian Stimulation and Human Uterine Lavage

An interventional study of Uterine lavage in Infertility, Female, sponsored by Previvo Genetics. Status unknown at 1 site in Mexico. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Previvo Genetics · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Infertility, Female

Keywords

  • uterine lavage
  • intrauterine insemination
  • embryo
  • blastocyst
  • in vivo
  • superovulation
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureUterine lavage

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

05

What researchers measure

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.

    Time frame: 30-Days

Secondary outcomes

  1. Recovery of Embryos

    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).

    Time frame: 1 Day

06

Study locations

1 of 1 sites recruiting
  • Punta Mita Hospital
    Punta de Mita, Nayarit 63734, Mexico
    Recruiting
07

References and documents

Publications

  • 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. Erratum In: Hum Reprod. 2021 Jun 18;36(7):2069-2070. doi: 10.1093/humrep/deab097. PubMed 31886877 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03426007
Lead sponsor
Previvo Genetics
Responsible party
Sponsor
First posted
Feb 8, 2018
Start date
Sep 1, 2017
Primary completion
Nov 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 30, 2019

Study contacts

Alex Nidal
Contact
anidal@previvogenetics.com
323-420-6343
Gheda Sahyun, MA
Contact
gsahyun@previvo.com
650-823-9093
Gheda Sahyun, MA
study director · Sponsor GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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