Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle

NCT03387059 | Terminated Phase 4 Results DMC

• 1 other identifier: MS700623-0009
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 7

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).

Conditions

Infertility

Keywords

Infertility; Forielle; Assisted Reproductive Technique (ART); Controlled Ovarian Stimulation (COS)

Outcome Measures

Primary Outcomes (1)

• Implantation Rate

  Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.

  Post Embryo Transfer (PET) Days 21 to 28

Secondary Outcomes (3)

• Number of Participants With Positive and Negative Pregnancy

  At Post Embryo Transfer (PET) Day 14

• 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

Study Arms (2)

Forielle Endometrial Washing

EXPERIMENTAL

Device: Forielle

No Endometrial Washing

NO INTERVENTION

Interventions

Forielle DEVICE

Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).

Forielle Endometrial Washing

Eligibility Criteria

• Age: Up to 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono S.P.A., Italy: collaborator

Study Sites (7)

Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica

Cattolica, 47841, Italy

Location

Centro di Procreazione Assistita Demetra

Florence, 50100, Italy

Location

Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia

Lucca, 55041, Italy

Location

Humanitas Fertility Center

Milan, 20089, Italy

Location

Centro Scienze della Natalità - IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Unità Operativa di Ginecologia - Istituti Clinici Zucchi

Monza, 20052, Italy

Location

Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Limitations and Caveats

The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: December 29, 2017
• Study Start: January 12, 2018
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: September 24, 2019
• Results First Posted: September 24, 2019

Record last verified: 2019-08

Locations

IT (7)