Oxytocin Antagonist in Patients With Repeated Failure of Implantation

Implantation Failure Clinical Trial

Official title:

Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673399
• Other study ID #: 2012-000278-49
• Status: Completed
• Phase: Phase 4
• Start date: February 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2021
• Source: AZ Jan Palfijn Gent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients with endocrinological diseases or problems

Related Conditions & MeSH terms

• Implantation Failure

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Jan Palfijn	Gent	Oost-vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
AZ Jan Palfijn Gent	Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implantation rate	the number of patients that show a positive serum blood pregnancy test	16 days from eggretrieval
Secondary	pregnancy rate	The number of patients with an ongoing first trimester pregnancy	12 weeks