Clinical trial NCT03426007: Controlled Ovarian Stimulation and Human Uterine Lavage
Official title: Controlled Ovarian Stimulation and Human Uterine Lavage: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Keywords: uterine lavage
intrauterine insemination
embryo
blastocyst
in vivo
superovulation
Lead sponsor: Previvo Genetics
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Serious Adverse Event Collection
timeFrame: 30-Days
Secondary outcomes:
measure: Recovery of Embryos
timeFrame: 1 Day
Other outcomes:
Locations:
city: Punta de Mita
country: Mexico
facility: Punta Mita Hospital
state: Nayarit
Study officials:
affiliation: Sponsor GmbH
name: Gheda Sahyun, MA
role: STUDY_DIRECTOR
References:
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.