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Clinical Trials/NCT04709796
NCT04709796RecruitingNot Applicable

The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients

University Hospital, Ghent1 site in 1 country178 target enrollmentStarted: March 3, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
178
Locations
1
Primary Endpoint
Live birth
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention group: EmbryoGlue

Experimental

Embryo transfer with EmbryoGlue®

Intervention: EmbryoGlue®, Vitrolife (Drug)

Control group

Active Comparator

Conventional embryo transfer

Intervention: Conventional Transfer (Drug)

Outcomes

Primary Outcomes

Live birth

Time Frame: 9 months after embryo transfer

live birth per randomized subject.

Secondary Outcomes

  • positive hCG(11 days (± 2 days) after embryo transfer.)
  • ongoing pregnancy rate(between 6 and 8 weeks of gestation)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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The Use of High Concentration Hyaluronic... | Clinical Trial