NCT01673399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

August 23, 2012

Last Update Submit

February 1, 2021

Conditions

Implantation Failure

Keywords

repeated implantation failure (RIF)atosibanpregnancy

Outcome Measures

Primary Outcomes (1)

  • implantation rate

    the number of patients that show a positive serum blood pregnancy test

    16 days from eggretrieval

Secondary Outcomes (1)

  • pregnancy rate

    12 weeks

Study Arms (2)

Atosiban

ACTIVE COMPARATOR

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

Drug: Atosiban

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

AtosibanDRUG

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

Atosiban
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • patients with endocrinological diseases or problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Jan Palfijn

Ghent, Oost-vlaanderen, 9000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 34467530DERIVED

MeSH Terms

Interventions

atosiban

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
gynecologist

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 28, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations

BE(1)