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Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01493440
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : December 20, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Repeated Implantation Failure Drug: atosiban

Detailed Description:
Atosiban is a mixed oxytocin and vasopressin V1A receptor antagonist.Combined antagonism at oxytocin and vasopressin V1A receptors reduces uterine contractions with a corresponding decrease in intrauterine production of prostaglandin F2alpha and improved uterine blood supply. These effects are of potential benefit for implantation support during IVF-ET cycles.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure
Study Start Date : March 2011
Primary Completion Date : August 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Atosiban Drug: atosiban
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.
Other Name: Tractocile


Outcome Measures

Primary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 5 weeks after intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493440


Locations
Vietnam
IVFAS, An Sinh Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam, 8
Sponsors and Collaborators
An Sinh Hospital
Vietnam National University
Investigators
Principal Investigator: Lan TN Vuong, MD University of Medicine and Pharmacy of Ho Chi Minh City
More Information

Publications:
Responsible Party: Vuong Thi Ngoc Lan, Lecturer and Researcher, Department of Obstetrics and Gynecology, Ho Chi Minh City University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT01493440     History of Changes
Other Study ID Numbers: IVFAS1103
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by Vuong Thi Ngoc Lan, Ho Chi Minh City University of Medicine and Pharmacy:
atosiban
clinical pregnancy
implantation rate
uterine contractility
IVF-ET

Additional relevant MeSH terms:
Atosiban
Vasotocin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Tocolytic Agents
Reproductive Control Agents
Oxytocics
Vasoconstrictor Agents