Back to resultsControlled Ovarian Stimulation and Human Uterine Lavage
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Uterine lavage
Sponsored by
About this trial
This is an interventional basic science trial for Infertility, Female focused on measuring uterine lavage, intrauterine insemination, embryo, blastocyst, in vivo, superovulation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Allergic to study materials, supplies and medication
- Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator
Sites / Locations
- Punta Mita HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Uterine Lavage
Arm Description
Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03426007
Brief Title
Controlled Ovarian Stimulation and Human Uterine Lavage
Official Title
Controlled Ovarian Stimulation and Human Uterine Lavage: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Previvo Genetics
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
uterine lavage, intrauterine insemination, embryo, blastocyst, in vivo, superovulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Uterine Lavage
Arm Type
Experimental
Arm Description
Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
Intervention Type
Procedure
Intervention Name(s)
Uterine lavage
Intervention Description
embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
Primary Outcome Measure Information:
Title
Serious Adverse Event Collection
Description
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 Outcome Measure Information:
Title
Recovery of Embryos
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Allergic to study materials, supplies and medication
Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Nidal
Phone
323-420-6343
Email
anidal@previvogenetics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gheda Sahyun, MA
Phone
650-823-9093
Email
gsahyun@previvo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gheda Sahyun, MA
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Punta Mita Hospital
City
Punta de Mita
State/Province
Nayarit
ZIP/Postal Code
63734
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Najmabadi, MD
Phone
310-466-5132
Email
najmabadi@reproductibe.org
First Name & Middle Initial & Last Name & Degree
Sam Najmabadi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31886877
Citation
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.
Results Reference
derived
Learn more about this trial
Controlled Ovarian Stimulation and Human Uterine Lavage
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