The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients (RIFLE)
Primary Purpose
IVF, Embryo Loss, Miscarriage, Recurrent
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
EmbryoGlue®, Vitrolife
Conventional Transfer
Sponsored by
About this trial
This is an interventional treatment trial for IVF
Eligibility Criteria
Inclusion Criteria:
- The trial only includes women with a clinical indication for ART with a history of RIF defined as the absence of implantation after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos was no less than four for cleavage-stage embryos and no less than two for blastocysts, with all embryos being of good quality and of appropriate developmental stage.
Furthermore, other specific 'RIF' investigations were performed and treated if necessary:
- Normal hysteroscopy
- Normal karyotype of both parents
- Coagulation screening (Antitrombine II deficiency, Factor VIII augmentation, APC resistance, Factor V + Factor II augmentation, Protein S and C deficiency an homocysteine augmentation)
- Auto-immune screening (Lupus anticoagulant, Rheumatoid Factor, Anti-nuclear antibodies, Anti-cardiolipine antibodies and Glycoprotein-1-antibodies)
Exclusion Criteria:
• Simultaneous participation in another clinical study
- Untreated and uncontrolled thyroid dysfunction
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
- Ovarian cysts or enlarged ovaries
- Malformations of the reproductive organs
- Moderate or severe hepatic impairment
- Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy
- Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation
- Couples needing TESE/MESA material
Sites / Locations
- UZ GhentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group: EmbryoGlue
Control group
Arm Description
Embryo transfer with EmbryoGlue®
Conventional embryo transfer
Outcomes
Primary Outcome Measures
Live birth
live birth per randomized subject.
Secondary Outcome Measures
positive hCG
cumulative positive hCG rate confirmed by blood sample
ongoing pregnancy rate
cumulative ongoing pregnancy rate per randomized subject, confirmed by ultrasound
Full Information
NCT ID
NCT04709796
First Posted
December 16, 2020
Last Updated
April 27, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04709796
Brief Title
The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients
Acronym
RIFLE
Official Title
The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a pilot study with the aim to investigate the beneficial effect of bicarbonate buffered medium containing hyaluronan and recombinant human albumin (EmbryoGlue®, Vitrolife) in patients with documented repeated implantation failure on live birth per randomized subject as primary endpoint.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IVF, Embryo Loss, Miscarriage, Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group: EmbryoGlue
Arm Type
Experimental
Arm Description
Embryo transfer with EmbryoGlue®
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Conventional embryo transfer
Intervention Type
Drug
Intervention Name(s)
EmbryoGlue®, Vitrolife
Intervention Description
The intervention under study is the application of EmbryoGlue®, a class III medical device (CE Marked). EmbryoGlue® is a bicarbonate buffered medium containing recombinant human albumin, hyaluronan and gentamicin as an antibacterial agent.
Intervention Type
Drug
Intervention Name(s)
Conventional Transfer
Intervention Description
The control arm is the conventional embryo transfer without Embryo glue medium
Primary Outcome Measure Information:
Title
Live birth
Description
live birth per randomized subject.
Time Frame
9 months after embryo transfer
Secondary Outcome Measure Information:
Title
positive hCG
Description
cumulative positive hCG rate confirmed by blood sample
Time Frame
11 days (± 2 days) after embryo transfer.
Title
ongoing pregnancy rate
Description
cumulative ongoing pregnancy rate per randomized subject, confirmed by ultrasound
Time Frame
between 6 and 8 weeks of gestation
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The trial only includes women with a clinical indication for ART with a history of RIF defined as the absence of implantation after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos was no less than four for cleavage-stage embryos and no less than two for blastocysts, with all embryos being of good quality and of appropriate developmental stage.
Furthermore, other specific 'RIF' investigations were performed and treated if necessary:
Normal hysteroscopy
Normal karyotype of both parents
Coagulation screening (Antitrombine II deficiency, Factor VIII augmentation, APC resistance, Factor V + Factor II augmentation, Protein S and C deficiency an homocysteine augmentation)
Auto-immune screening (Lupus anticoagulant, Rheumatoid Factor, Anti-nuclear antibodies, Anti-cardiolipine antibodies and Glycoprotein-1-antibodies)
Exclusion Criteria:
• Simultaneous participation in another clinical study
Untreated and uncontrolled thyroid dysfunction
Tumors of the ovary, breast, uterus, pituitary or hypothalamus
Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
Ovarian cysts or enlarged ovaries
Malformations of the reproductive organs
Moderate or severe hepatic impairment
Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy
Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation
Couples needing TESE/MESA material
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Stoop, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Stoop
Phone
09/332.16.99
Email
dominic.stoop@uzgent.be
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients
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