Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle (ENDOMEDE)

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 4

Conditions

Infertility

Treatments

Device: Forielle

Study type

Interventional

Funder types

Industry

Identifiers

NCT03387059

MS700623-0009

Details and patient eligibility

About

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).

Enrollment

9 patients

Sex

Female

Ages

Under 41 years old

Volunteers

No Healthy Volunteers

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