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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).
Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica
Cattolica, Italy
Centro di Procreazione Assistita Demetra
Florence, Italy
Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia
Lucca, Italy
Humanitas Fertility Center
Milan, Italy
Implantation Rate
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
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.
Time frame: 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).
Time frame: 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.
Time frame: Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84
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Centro Scienze della Natalità - IRCCS Ospedale San Raffaele
Milan, Italy
Unità Operativa di Ginecologia - Istituti Clinici Zucchi
Monza, Italy
Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA
Torino, Italy