Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle

Infertility Clinical Trial

— ENDOMEDE  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03387059
• Other study ID #: MS700623-0009
• Status: Terminated
• Phase: Phase 4
• Start date: January 12, 2018
• Est. completion date: June 12, 2018

Study information

• Verified date: August 2019
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Reproductive Technique (ART).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 41 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Forielle
Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).

Locations

Country	Name	City	State
Italy	Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica	Cattolica
Italy	Centro di Procreazione Assistita Demetra	Firenze
Italy	Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia	Lucca
Italy	Centro Scienze della Natalità - IRCCS Ospedale San Raffaele	Milano
Italy	Humanitas Fertility Center	Milano
Italy	Unità Operativa di Ginecologia - Istituti Clinici Zucchi	Monza
Italy	Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany	Merck Serono S.P.A., Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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.	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).	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.	Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84