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

Primary Purpose

Infertility

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Forielle
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Forielle, Assisted Reproductive Technique (ART), Controlled Ovarian Stimulation (COS)

Eligibility Criteria

undefined - 41 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica
  • Centro di Procreazione Assistita Demetra
  • Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia
  • Humanitas Fertility Center
  • Centro Scienze della Natalità - IRCCS Ospedale San Raffaele
  • Unità Operativa di Ginecologia - Istituti Clinici Zucchi
  • Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Forielle Endometrial Washing

No Endometrial Washing

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Positive and Negative Pregnancy
Positive and Negative Pregnancy measured by Day 14 serum beta Human chorionic gonadotropin (Beta-HCG) pregnancy test.
Number of Participants With Confirmed Ongoing Pregnancy
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
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.

Full Information

First Posted
December 22, 2017
Last Updated
August 23, 2019
Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono S.P.A., Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03387059
Brief Title
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
Acronym
ENDOMEDE
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
June 12, 2018 (Actual)
Study Completion Date
June 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono S.P.A., Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Forielle, Assisted Reproductive Technique (ART), Controlled Ovarian Stimulation (COS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forielle Endometrial Washing
Arm Type
Experimental
Arm Title
No Endometrial Washing
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Forielle
Intervention Description
Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).
Primary Outcome Measure Information:
Title
Implantation Rate
Description
Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.
Time Frame
Post Embryo Transfer (PET) Days 21 to 28
Secondary Outcome Measure Information:
Title
Number of Participants With Positive and Negative Pregnancy
Description
Positive and Negative Pregnancy measured by Day 14 serum beta Human chorionic gonadotropin (Beta-HCG) pregnancy test.
Time Frame
At Post Embryo Transfer (PET) Day 14
Title
Number of Participants With Confirmed Ongoing Pregnancy
Description
Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by obstetric ultrasound (transvaginal or abdominal).
Time Frame
Post Embryo Transfer (PET) Days 70 to 84
Title
Number of Participants With Device Incidents
Description
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.
Time Frame
Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica
City
Cattolica
ZIP/Postal Code
47841
Country
Italy
Facility Name
Centro di Procreazione Assistita Demetra
City
Firenze
ZIP/Postal Code
50100
Country
Italy
Facility Name
Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia
City
Lucca
ZIP/Postal Code
55041
Country
Italy
Facility Name
Humanitas Fertility Center
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Centro Scienze della Natalità - IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Unità Operativa di Ginecologia - Istituti Clinici Zucchi
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

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Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle

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