Controlled Ovarian Stimulation and Human Uterine Lavage

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03426007
• Date of registration: 29/01/2018
• Prospective Registration: No
• Primary sponsor: Previvo Genetics
• Public title: Controlled Ovarian Stimulation and Human Uterine Lavage
• Scientific title: Controlled Ovarian Stimulation and Human Uterine Lavage: A Feasibility Study
• Date of first enrolment: September 1, 2017
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03426007
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Gheda Sahyun, MA
• Affiliation: Sponsor GmbH

• Name: Alex Nidal

• Name: Sam Najmabadi, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility, Female

Intervention(s)

Procedure: Uterine lavage

Primary Outcome(s)

Serious Adverse Event Collection [Time Frame: 30-Days]

Secondary Outcome(s)

Recovery of Embryos [Time Frame: 1 Day]

Secondary ID(s)

TD-2104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors