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

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ClinicalTrials.gov Identifier: NCT03387059
Recruitment Status : Terminated (The study has been terminated due to exiguous number of participants and data available.)
First Posted : December 29, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Merck Serono S.P.A., Italy
Information provided by (Responsible Party):
Merck KGaA

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).

Condition or disease Intervention/treatment Phase
Infertility Device: Forielle Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 16, 2018
Actual Primary Completion Date : June 12, 2018
Actual Study Completion Date : June 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Forielle Endometrial Washing Device: Forielle
Eligible subjects will be randomized to receive Forielle endometrial washing following oocyte retrieval on Study Day 0.

No Intervention: No Endometrial Washing



Primary Outcome Measures :
  1. Subject Implantation Rate [ Time Frame: Post Embryo Transfer (PET) Days 21 to 28 ]
    Subject implantation rate is defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.


Secondary Outcome Measures :
  1. Number of Subjects With Positive and Negative Pregnancy Result [ Time Frame: Post Embryo Transfer (PET) Day 14 ]
  2. Number of Subjects With Confirmed Ongoing Pregnancy [ Time Frame: Post Embryo Transfer (PET) Days 70 to 84 ]
    Ongoing pregnancy will be confirmed via obstetric ultrasound (transvaginal or abdominal).

  3. Number of Subjects With Device Incidents [ Time Frame: 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 patient, or user or of other persons or to a serious deterioration in their state of health.



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Ages Eligible for Study:   up to 41 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387059


Locations
Italy
Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica
Cattolica, Italy, 47841
Centro di Procreazione Assistita Demetra
Firenze, Italy, 50100
Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia
Lucca, Italy, 55041
Humanitas Fertility Center
Milano, Italy, 20089
Centro Scienze della Natalità - IRCCS Ospedale San Raffaele
Milano, Italy, 20132
Unità Operativa di Ginecologia - Istituti Clinici Zucchi
Monza, Italy, 20052
Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA
Torino, Italy, 10126
Sponsors and Collaborators
Merck KGaA
Merck Serono S.P.A., Italy
Investigators
Study Director: Medical Responsible Merck Serono S.P.A., Italy

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT03387059     History of Changes
Other Study ID Numbers: MS700623-0009
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck KGaA:
Infertility
Forielle
Assisted Reproductive Technique (ART)
Controlled Ovarian Stimulation (COS)

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female