Status:
TERMINATED
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.P.A., Italy
Conditions:
Infertility
Eligibility:
FEMALE
Up to 41 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03387059
Start Date
January 12 2018
End Date
June 12 2018
Last Update
September 24 2019
Active Locations (7)
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1
Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica
Cattolica, Italy, 47841
2
Centro di Procreazione Assistita Demetra
Florence, Italy, 50100
3
Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia
Lucca, Italy, 55041
4
Humanitas Fertility Center
Milan, Italy, 20089