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, Germany7 sites in 1 country9 target enrollmentJanuary 12, 2018

ConditionsInfertility

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Infertility
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 9
Locations: 7
Primary Endpoint: Implantation Rate
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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).

Registry

clinicaltrials.gov

Start Date

January 12, 2018

End Date

June 12, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility Criteria

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)

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

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)