Infertility
Conditions
Keywords
Infertility, Forielle, Assisted Reproductive Technique (ART), Controlled Ovarian Stimulation (COS)
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 favorable endometrial condition to implantation after Controlled Ovarian Stimulation (COS) during Assisted Reproductive Technique (ART).
Interventions
DEVICEForielle
Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).
Sponsors
Merck Serono S.P.A., Italy
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 41 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implantation Rate | Post Embryo Transfer (PET) Days 21 to 28 | Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive and Negative Pregnancy | At Post Embryo Transfer (PET) Day 14 | Positive and Negative Pregnancy measured by Day 14 serum beta Human chorionic gonadotropin (Beta-HCG) pregnancy test. |
| Number of Participants With Confirmed Ongoing Pregnancy | Post Embryo Transfer (PET) Days 70 to 84 | Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by obstetric ultrasound (transvaginal or abdominal). |
| Number of Participants With Device Incidents | 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 participant, or user or of other persons or to a serious deterioration in their state of health. |
Countries
Italy
Participant flow
Pre-assignment details
Nine participants were enrolled and the study was prematurely terminated due to the poor feasibility and sustainability, leading to slow recruitment rate.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 5 |
| 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). | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study termination | 5 | 4 |
Baseline characteristics
| Characteristic | Forielle Endometrial Washing | No Endometrial Washing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
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
Population: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.
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).
Time frame: Post Embryo Transfer (PET) Days 70 to 84
Population: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.
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.
Time frame: Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84
Population: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.
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.
Time frame: At Post Embryo Transfer (PET) Day 14
Population: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.