NCT01493440

Brief Summary

Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro fertilization and embryo transfer).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

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

March 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

December 14, 2011

Last Update Submit

December 16, 2011

Conditions

Repeated Implantation Failure

Keywords

atosibanclinical pregnancyimplantation rateuterine contractilityIVF-ET

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    5 weeks after intervention

Study Arms (1)

Atosiban

OTHER
Drug: atosiban

Interventions

atosibanDRUG

Atosiban was administered as a 6.75mg IV bolus dose 30 minutes prior to embryo transfer followed by a 1-hour IV infusion at dose of 18 mg/h then a 2-hour IV infusion at 6 mg/h.

Also known as: Tractocile
Atosiban

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • had repeated implantation failure
  • have at least 1 good quality embryo for transfer

You may not qualify if:

  • uterine abnormalities that could compromise the implantation process (e.g. fibroids, endometrial polyp, bicornuate uterus, adhesion of uterine cavity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVFAS, An Sinh Hospital

Ho Chi Minh City, Ho Chi Minh, 8, Vietnam

Location

Related Publications (1)

  • Moraloglu O, Tonguc E, Var T, Zeyrek T, Batioglu S. Treatment with oxytocin antagonists before embryo transfer may increase implantation rates after IVF. Reprod Biomed Online. 2010 Sep;21(3):338-43. doi: 10.1016/j.rbmo.2010.04.009. Epub 2010 Apr 18.

    PMID: 20638340BACKGROUND

MeSH Terms

Interventions

atosiban

Study Officials

  • Lan TN Vuong, MD

    University of Medicine and Pharmacy of Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer and Researcher, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 16, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations

VN(1)