Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle

Phase 4

Terminated

• Conditions: Infertility
• Interventions: Device: Forielle

• Registration Number: NCT03387059
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2017-12-29
• Study Start: 2018-01-12
• Primary Completion: 2018-06-12
• Study Completion: 2018-06-12
• Results First Submitted: 2019-06-03
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-23
• Last Update Submitted: 2019-08-23
• Results First Posted: 2019-09-24
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Forielle Endometrial Washing	Forielle	-

Primary Outcome Measures

Name	Time	Method
Implantation Rate	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 Outcome Measures

Name	Time	Method
Number of Participants With Confirmed Ongoing Pregnancy	Post Embryo Transfer (PET) Days 70 to 84	Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by obstetric ultrasound (transvaginal or abdominal).
Number of Participants With Device Incidents	Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84	A medical device incident is any malfunction or deterioration in the characteristics and/or clinical performance of a device, as well as any inadequacy in the labelling or the instructions for use (IFU) which, directly or indirectly, might lead to or might have led to the death of a participant, or user or of other persons or to a serious deterioration in their state of health.
Number of Participants With Positive and Negative Pregnancy	At Post Embryo Transfer (PET) Day 14	Positive and Negative Pregnancy measured by Day 14 serum beta Human chorionic gonadotropin (Beta-HCG) pregnancy test.

Trial Locations

Locations (7)

Centro di Procreazione Assistita Demetra; 🇮🇹 Firenze, Italy

Humanitas Fertility Center; 🇮🇹 Milano, Italy

Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia; 🇮🇹 Lucca, Italy

Unità Operativa di Ginecologia - Istituti Clinici Zucchi; 🇮🇹 Monza, Italy

Centro Scienze della Natalità - IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy

Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA; 🇮🇹 Torino, Italy

Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica; 🇮🇹 Cattolica, Italy