NCT01501214

Brief Summary

The hypothesis of this randomized double blind study is that the live birth rates are significantly higher after the use of atosiban prior to the embryo transfer in patients undergoing in vitro fertilization (IVF) treatment. This study aims to compare the live birth rates of IVF treatment between patients receiving atosiban and placebo prior to the transfer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2011

Geographic Reach
2 countries

2 active sites

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

December 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

December 20, 2011

Last Update Submit

January 6, 2014

Conditions

Subfertility

Keywords

atosibanin vitro fertilizationsubfertility

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    9 months

Secondary Outcomes (1)

  • Ongoing pregnancy rate

    3 months

Study Arms (2)

Atosiban

ACTIVE COMPARATOR
Drug: Atosiban

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Normal saline

Interventions

AtosibanDRUG

Patients in the atosiban group will receive intravenous atosiban 30 min before the transfer with a bolus dose of 6.75 mg, and the infusion will be continued with an infusion rate of 18 mg/h. After performing ET, the dose of atosiban will be reduced to 6 mg/h and the infusion will be continued for 2 hours (total administered dose: 37.5 mg). Those in the placebo group will receive normal saline only.

Also known as: Tractocile
Atosiban
Normal salineDRUG

Normal saline given

Placebo

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \< 43 years
  • Normal uterine cavity shown on ultrasound scanning

You may not qualify if:

  • Age \>=43
  • Three previous IVF cycles
  • Use of donor oocytes
  • Natural IVF or IVM cycles
  • Abnormal uterine cavity on ultrasound scanning
  • ET canceled because of absent fertilization or risk of ovarian hyperstimulation syndrome
  • Blastocyst transfer
  • Undergoing preimplantation genetic diagnosis
  • Recruited in the same study before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reproductive Medical Center of Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

CGRH, School of Medicine

Ho Chi Minh City, Ho Chi Minh City, Vietnam

Location

Related Publications (14)

  • Ayoubi JM, Epiney M, Brioschi PA, Fanchin R, Chardonnens D, de Ziegler D. Comparison of changes in uterine contraction frequency after ovulation in the menstrual cycle and in in vitro fertilization cycles. Fertil Steril. 2003 May;79(5):1101-5. doi: 10.1016/s0015-0282(03)00179-1.

    PMID: 12738502BACKGROUND

  • Bernabeu R, Roca M, Torres A, Ten J. Indomethacin effect on implantation rates in oocyte recipients. Hum Reprod. 2006 Feb;21(2):364-9. doi: 10.1093/humrep/dei343. Epub 2005 Nov 10.

    PMID: 16284067BACKGROUND

  • Blockeel C, Pierson R, Popovic-Todorovic B, Visnova HA, Garcı´a-Velasco HA, Mra´zek M, Barri PN, Pierzynski P, Kuczynski W, Devroey P, Breinholt V, Erichsen L, Klein BM, Arce JC. Effects of barusiban and atosiban on frequency of uterine contractions in the luteal phase after stimulation: a randomized placebo controlled trial. Hum. Reprod. 24 (Suppl. 1), i26, 2009.

    BACKGROUND

  • Fanchin R, Ayoubi JM. Uterine dynamics: impact on the human reproduction process. Reprod Biomed Online. 2009;18 Suppl 2:57-62. doi: 10.1016/s1472-6483(10)60450-6.

    PMID: 19406033BACKGROUND

  • Fanchin R, Righini C, Olivennes F, Taylor S, de Ziegler D, Frydman R. Uterine contractions at the time of embryo transfer alter pregnancy rates after in-vitro fertilization. Hum Reprod. 1998 Jul;13(7):1968-74. doi: 10.1093/humrep/13.7.1968.

    PMID: 9740459BACKGROUND

  • Liedman R, Hansson SR, Howe D, Igidbashian S, McLeod A, Russell RJ, Akerlund M. Reproductive hormones in plasma over the menstrual cycle in primary dysmenorrhea compared with healthy subjects. Gynecol Endocrinol. 2008 Sep;24(9):508-13. doi: 10.1080/09513590802306218.

    PMID: 18958771BACKGROUND

  • Moon HS, Park SH, Lee JO, Kim KS, Joo BS. Treatment with piroxicam before embryo transfer increases the pregnancy rate after in vitro fertilization and embryo transfer. Fertil Steril. 2004 Oct;82(4):816-20. doi: 10.1016/j.fertnstert.2004.02.140.

    PMID: 15482753BACKGROUND

  • Pierson R, Deptuch JJ, Invik J, Klein BM, Breinholt V, Arce JC. Reproducibility of uterine contractility assessments based on transvaginal ultrasound cine-loop recordings. Hum. Reprod. 24 (Suppl. 1), i103, 2009.

    BACKGROUND

  • Pierzynski P, Gajda B, Smorag Z, Rasmussen AD, Kuczynski W. Effect of atosiban on rabbit embryo development and human sperm motility. Fertil Steril. 2007 May;87(5):1147-52. doi: 10.1016/j.fertnstert.2006.08.089. Epub 2007 Jan 16.

    PMID: 17224148BACKGROUND

  • Richter ON, Kubler K, Schmolling J, Kupka M, Reinsberg J, Ulrich U, van der Ven H, Wardelmann E, van der Ven K. Oxytocin receptor gene expression of estrogen-stimulated human myometrium in extracorporeally perfused non-pregnant uteri. Mol Hum Reprod. 2004 May;10(5):339-46. doi: 10.1093/molehr/gah039. Epub 2004 Mar 25.

    PMID: 15044599BACKGROUND

  • Tsirigotis M, Pelekanos M, Gilhespie S, Gregorakis S, Pistofidis G. Ritodrine use during the peri-implantation period reduces uterine contractility and improves implantation and pregnancy rates post-ivf. Hum. Reprod. 15, (Abs. Bk 1), O-024, 10, 2000.

    BACKGROUND

  • Vedernikov Y, Betancourt A, Shi S, Shi L, Reinheimer T, Garfield R. (2006) Oxytocin antagonistic effect of barusiban and atosiban in isolated uterine artery from late pregnant rats. In: Annual scientific meeting of the Society for Gynecologic Investigation. Toronto, Canada.

    BACKGROUND

  • Visnova H, Coroleu B, Piro M, Blockeel C, Mrazek M, Arce JC. Barusiban and atosiban for reduction of uterine contractions on day of embryo transfer do not alter the endocrine profile at time of implantation. Hum. Reprod. 24 (Suppl. 1), i178, 2009.

    BACKGROUND

  • Ng EH, Li RH, Chen L, Lan VT, Tuong HM, Quan S. A randomized double blind comparison of atosiban in patients undergoing IVF treatment. Hum Reprod. 2014 Dec;29(12):2687-94. doi: 10.1093/humrep/deu263. Epub 2014 Oct 21.

    PMID: 25336707DERIVED

MeSH Terms

Conditions

Infertility

Interventions

atosibanSaline Solution

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ernest HY Ng, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 29, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

VN(1)CN(1)