Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle (ENDOMEDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Device: Forielle||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Forielle Endometrial Washing||
Eligible subjects will be randomized to receive Forielle endometrial washing following oocyte retrieval on Study Day 0.
|No Intervention: No Endometrial Washing|
- 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.
- Number of Subjects With Positive and Negative Pregnancy Result [ Time Frame: Post Embryo Transfer (PET) Day 14 ]
- 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).
- 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.
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
|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|
|Study Director:||Medical Responsible||Merck Serono S.P.A., Italy|