Oxytocin Antagonist in Patients With Repeated Failure of Implantation

NCT ID: NCT01673399

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Implantation Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Atosiban

Patients receive a bolus injection of 6.75mg atosiban and following an atosibaninfusion at 18mg/u during 3 hours.

Group Type ACTIVE_COMPARATOR

Atosiban

Intervention Type DRUG

Bolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer.

placebo

Patients receive a placebo bolus injection (NaCl 0.9%)and an infusion of NaCl 0.9% during 3 hours

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Atosiban

Bolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer.

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* IVF/ ICSI patients below 38 years
* 2e to 6e IVF-cycle

Exclusion Criteria

* patients with endocrinological diseases or problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouw Hospital

OTHER

Sponsor Role collaborator

AZ Jan Palfijn Gent

OTHER

Sponsor Role lead

Responsible Party

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Dr. Decleer Wim

gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AZ Jan Palfijn

Ghent, Oost-vlaanderen, Belgium

Site Status

Countries

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Belgium

References

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Craciunas L, Tsampras N, Kollmann M, Raine-Fenning N, Choudhary M. Oxytocin antagonists for assisted reproduction. Cochrane Database Syst Rev. 2021 Sep 1;9(9):CD012375. doi: 10.1002/14651858.CD012375.pub2.

Reference Type DERIVED
PMID: 34467530 (View on PubMed)

Other Identifiers

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2012-000278-49

Identifier Type: -

Identifier Source: org_study_id

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