NCT03387059TerminatedPhase 4
A Multicentre, Prospective Randomised Controlled, Interventional Clinical Investigation to Assess the Clinical Safety and Performance of Forielle, a Medical Device for Endometrial Washing in Restoring Favorable Endometrial Condition to Implantation After COS During Assisted Reproductive Practice (ENDOMEDE)
Merck KGaA, Darmstadt, Germany14 sites in 1 country9 target enrollmentStarted: January 12, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 9
- Locations
- 14
- Primary Endpoint
- Implantation Rate
Study Overview
Brief Summary
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial condition to implantation after Controlled Ovarian Stimulation (COS) during Assisted Reproductive Technique (ART).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 41 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All infertile women treated with intracytoplasmic sperm injection (ICSI)/Fertilization in Vitro and Embryo Transfer (FIVET)
- •Less than or equal to (<=) 1 previous failed embryo transfer
- •Eumenorrheic normo-gonadotropic women
- •Basal follicle-stimulating hormone (FSH) <=12 International unit per liter (IU/L)
- •Anti-mullerian hormone (AMH) greater than (>) 1.1 nanogram per milliliter (ng/mL)
- •Ovarian Reserve: number of antral follicles 2 millimeter (mm) between 6 <= antral follicle count (AFC) <= 16
- •Follicles > 16 mm at the triggering day between 5-14
- •Body Mass Index (BMI) between 18 <= BMI <= 27 kilogram per meter square (kg/m^2)
- •Indication for Fresh Embryo transfer
- •Normal uterine cavity on ultrasound exam (e.g., no presence of hydrosalpinx)
- •Undergoing Assisted Reproductive Technique (ART) and oocyte maturation by human chorionic gonadotropin (HCG) triggering
- •Progesterone (P4) serum level at the HCG triggering day <= 1.5 ng/mL (Day O/Randomization)
- •Estradiol (E2) <= 3000 picogram/milliliter (pg/mL) at the human chorionic gonadotropin (HCG) triggering day (Day 0/Randomization)
- •Subjects must have read and signed the Informed Consent Form prior to study-specific-procedures not part of standard of care
- •Other protocol defined inclusion criteria could apply
Exclusion Criteria
- •Clinically significant systemic disease (such as diabetes, metabolic syndrome, immunological diseases, diagnosed thrombophilia, porphyria, or any other medical condition requiring the use of low-molecular weight heparin therapy)
- •Polycystic ovary syndrome (PCOS) according to Rotterdam Consensus Criteria (European Society of Human Reproduction and Embryology [ESHRE]/American Society for Reproductive Medicine [ASRM], 2003)
- •Poor ovarian response (POR) according to the European Society of Human Reproduction and Embryology (ESHRE) Criteria
- •RIF (repeated implantation failure), defined as greater than or equals to (>=) 2 previous failed embryo transfers
- •Endometriosis III-IV stage or adenomyosis
- •Clinically significant findings on exam or ultrasound, such as salpingitis, hydrosalpynx or evidence of ovarian cysts
- •Known hypersensitivity to any of the components of the solution
- •Known hypersensitivity to vaginal progesterone or its excipients
- •Other protocol defined exclusion criteria could apply
Arms & Interventions
Forielle Endometrial Washing
Experimental
Intervention: Forielle (Device)
No Endometrial Washing
No Intervention
Outcomes
Primary Outcomes
Implantation Rate
Time Frame: Post Embryo Transfer (PET) Days 21 to 28
Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.
Secondary Outcomes
- Number of Participants With Confirmed Ongoing Pregnancy(Post Embryo Transfer (PET) Days 70 to 84)
- Number of Participants With Device Incidents(Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84)
- Number of Participants With Positive and Negative Pregnancy(At Post Embryo Transfer (PET) Day 14)
Investigators
Study Sites (14)
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