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The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.
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| Name | Class |
|---|---|
| Merck Serono S.P.A., Italy | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Forielle Endometrial Washing | Experimental |
| |
| No Endometrial Washing | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forielle | Device | Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Post Embryo Transfer (PET) Day 14 |
| Number of Participants With Confirmed Ongoing Pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica | Cattolica | 47841 | Italy | |||
Nine participants were enrolled and the study was prematurely terminated due to the poor feasibility and sustainability, leading to slow recruitment rate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Forielle Endometrial Washing | Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization). |
| FG001 | No Endometrial Washing | Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Intent-to-Treat (ITT) population included all randomized participants into the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Forielle Endometrial Washing | Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization). |
| BG001 | No Endometrial Washing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Implantation Rate | Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred. | Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate. | Posted | Post Embryo Transfer (PET) Days 21 to 28 |
|
Baseline up to Day 152
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Forielle Endometrial Washing | Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization). |
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The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2016 | Aug 23, 2019 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by obstetric ultrasound (transvaginal or abdominal). |
| 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. | Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84 |
| Centro di Procreazione Assistita Demetra |
| Florence |
| 50100 |
| Italy |
| Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia | Lucca | 55041 | Italy |
| Humanitas Fertility Center | Milan | 20089 | Italy |
| Centro Scienze della Natalità - IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Unità Operativa di Ginecologia - Istituti Clinici Zucchi | Monza | 20052 | Italy |
| Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA | Torino | 10126 | Italy |
Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | 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. | Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate. | Posted | At Post Embryo Transfer (PET) Day 14 |
|
|
| Secondary | 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). | Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate. | Posted | Post Embryo Transfer (PET) Days 70 to 84 |
|
|
| Secondary | 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. | Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate. | Posted | Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84 |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | No Endometrial Washing | Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization). | 0 | 4 | 0 | 4 | 0 | 4 |
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