Completed
Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.
What is being tested
Atosiban
+ placebo
Drug
Who is being recruted
From 18 to 38 Years
+3 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 4
Interventional
Study Start: February 2012
Summary
Principal SponsorAZ Jan Palfijn Gent
Last updated: February 2, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2012
Actual date on which the first participant was enrolled.In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate.
Principal SponsorAZ Jan Palfijn Gent
Last updated: February 2, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
138 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 38 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
2e to 6e IVF-cycle
IVF/ ICSI patients below 38 years
1 exclusion criteria prevent from participating
patients with endocrinological diseases or problems
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorPatients receive a bolus injection of 6.75mg atosiban and following an atosibaninfusion at 18mg/u during 3 hours.
Group II
PlaceboPatients receive a placebo bolus injection (NaCl 0.9%)and an infusion of NaCl 0.9% during 3 hours
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center