Clinical trial NCT03387059: Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: Infertility
Forielle
Assisted Reproductive Technique (ART)
Controlled Ovarian Stimulation (COS)
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono S.P.A., Italy
First posted: 2017-12-29
Enrollment: 9
Sex: FEMALE
Maximum age (years): 41
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)
* 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

Primary outcomes:
measure: Implantation Rate
timeFrame: Post Embryo Transfer (PET) Days 21 to 28
Secondary outcomes:
measure: Number of Participants With Positive and Negative Pregnancy
timeFrame: At Post Embryo Transfer (PET) Day 14
measure: Number of Participants With Confirmed Ongoing Pregnancy
timeFrame: Post Embryo Transfer (PET) Days 70 to 84
measure: Number of Participants With Device Incidents
timeFrame: Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84
Other outcomes:
Locations:
city: Cattolica
country: Italy
facility: Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica
city: Firenze
country: Italy
facility: Centro di Procreazione Assistita Demetra
city: Lucca
country: Italy
facility: Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia
city: Milano
country: Italy
facility: Humanitas Fertility Center
city: Milano
country: Italy
facility: Centro Scienze della Natalità - IRCCS Ospedale San Raffaele
city: Monza
country: Italy
facility: Unità Operativa di Ginecologia - Istituti Clinici Zucchi
city: Torino
country: Italy
facility: Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: