InfertilityPhase 4ENDOMEDENCT03387059
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
A Phase 4 study testing Forielle in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 7 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 41 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Forielle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 7 sitesItaly
- Study dates
- 12 Jan 2018to 12 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 41 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica
Cattolica, 47841
Centro di Procreazione Assistita Demetra
Florence, 50100
Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia
Lucca, 55041
Humanitas Fertility Center
Milan, 20089
Centro Scienze della Natalità - IRCCS Ospedale San Raffaele
Milan, 20132
Unità Operativa di Ginecologia - Istituti Clinici Zucchi
Monza, 20052
Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA
Torino, 10126
About this study
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)
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
- Being tested
- Forielle
- Keywords
- Infertility, Forielle, Assisted Reproductive Technique (ART), Controlled Ovarian Stimulation (COS)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForielleDevice
Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).
| Study group | Role | What they receive |
|---|---|---|
| Forielle Endometrial Washing | Experimental | Not described Receives: Device: Forielle |
| No Endometrial Washing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation Rate
Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.
Measured: Post Embryo Transfer (PET) Days 21 to 28
Secondary outcomes (3)
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.
Measured: At Post Embryo Transfer (PET) Day 14
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).
Measured: Post Embryo Transfer (PET) Days 70 to 84
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.
Measured: Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start12 Jan 2018
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
Why it stopped: The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.P.A., Italy
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387059
- Sponsor's protocol ID
- MS700623-0009
- Acronym
- ENDOMEDE
- Status last verified
- Aug 2019
- First submitted
- 22 Dec 2017
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03387059
- Acronym / sponsor ID
- ENDOMEDE / MS700623-0009
- Conditions
- Infertility
- Keywords
- Infertility, Forielle, Assisted Reproductive Technique (ART), Controlled Ovarian Stimulation (COS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.P.A., Italy
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Posted 24 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forielle Endometrial Washing | Experimental | Device: Forielle |
| No Endometrial Washing | No intervention | – |
Who may qualify
- Ages
- Up to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForielleParticipants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation). | Device | Forielle Endometrial Washing |
Primary outcome
Implantation Rate
Time frame: 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.
3 secondary outcomes
Number of Participants With Positive and Negative Pregnancy
Time frame: At Post Embryo Transfer (PET) Day 14
Number of Participants With Confirmed Ongoing Pregnancy
Time frame: Post Embryo Transfer (PET) Days 70 to 84
Number of Participants With Device Incidents
Time frame: Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Forielle in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation Rate (time frame: Post Embryo Transfer (PET) Days 21 to 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.