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Trial · Interventional

Status unknownPhase 1Registry data

A Randomized Double Blind Comparison of Atosiban in Patients With RIF Undergoing IVF Treatment

NCTNCT02893722 (opens ClinicalTrials.gov in a new tab)Other idFERRING-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 1
Enrollment
200 participants (estimated)
Sponsor
Shanghai First Maternity and Infant Hospital · Other
Design
Randomized · Triple masking
Countries
Not stated
Start
Jan 2017
Primary completion
Jan 2018 (estimated)
Completion
Dec 2018 (estimated)
First posted
8 Sept 2016 (estimated)
Last update posted
8 Sept 2016 (estimated)
Conditions
Repeated Implantation Failure

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 1

    A Randomized Double Blind Comparison of Atosiban in Patients With RIF Undergoing IVF Treatment

    NCT02893722

    Jan 2017 to est. Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study intends to carry out a prospective, randomized, double blind and controlled study to compare the influence of Atosiban and placebo on uterine contraction frequency, endometrial blood flow perfusion, oxytocin and serum concentration of PGF2α, embryo implantation rate and clinical pregnancy rate on the RIF population after fresh embryo transfer, so as to further clarify the curative effect of Atosiban in the treatment of RIF and provide evidence-based basis for Atosiban for application in RIF population.

Interventions

  • atosibanDrug
  • 0.9% salineDrug

Arms2

  • Experimental

    atosiban

    Give drugs 30 minutes before the start of the embryo transfer. First step: give a 37.5 mg Atosiban (Ferring, Germany) to take 0.9 ml, that is, 6.75 mg, conduct intravenous injection in one minute. Second step: for the remaining 4.1 ml, namely 30.75 mg, dilute to 41 ml, use the venous pump to adjust to 24 ml/h, infuse for 1 hour, namely 18 mg. Third step: for the remaining 17 ml, use the venous pump to adjust to 8 ml/h, infuse 2.1 hours, namely 12.75 mg. Total administration time is 3 hours, total dose is 37.5 mg.

  • Placebo comparator

    0.9% salain

    intravenous injection of 0.9% saline in one minute before transfer. Then use the same dose of normal saline for intravenous infusion to set the same infusion rate with experimental group, complete the infusion in 3 hours.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical pregnancy rate

    Time frame · 4 weeks after embryo transfer

    Registry description

    cases of clinical pregnancies / number of transplantation cycles(per patient)

Secondary outcomes(4)

  1. implantation rate

    Time frame · 4 weeks after embryo transfer

    Registry description

    number of pregnancy fetal bursa / total number of transplantation embryos

  2. abortion rate

    Time frame · 6 weeks after embryo transfer

    Registry description

    abortion cases / number of clinical pregnancy cycles

  3. ectopic pregnancy rate

    Time frame · 6 weeks after embryo transfer

    Registry description

    ectopic pregnancy cases / number of clinical pregnancy cycle

  4. frequency of uterine contraction (4 minutes)

    Time frame · 1 hour before and 1 hour after intervention

    Registry description

    times of uterine contraction/4 minutes

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies11

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2008

1 result

Reproductive hormones in plasma over the menstrual cycle in primary dysmenorrhea compared with healthy subjects.

Liedman et al. 2008Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinologycited by 42

PMID 18958771DOI 10.1080/09513590802306218PUB-18958771

Full text at the publisher1 result
Publisher pageSee results (1)

Indexing hint: Observational study · 2007

Effect of atosiban on rabbit embryo development and human sperm motility.

Pierzynski et al. 2007Fertility and sterilitycited by 23

PMID 17224148DOI 10.1016/j.fertnstert.2006.08.089PUB-17224148

Full text at the publisher
Publisher page

Indexing hint: Case report · 2007

Oxytocin antagonists may improve infertility treatment.

Pierzynski et al. 2007Fertility and sterilitycited by 50

PMID 17481622DOI 10.1016/j.fertnstert.2006.09.017PUB-17481622

Full text at the publisher
Publisher page

More studies

8 studies on this page

Indexing hint: Systematic review · 2021

Oxytocin antagonists for assisted reproduction.

Craciunas et al. 2021The Cochrane database of systematic reviewscited by 18

PMID 34467530PMC8408576DOI 10.1002/14651858.cd012375.pub2PUB-34467530

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2016

Administration of atosiban in patients with endometriosis undergoing frozen-thawed embryo transfer: a prospective, randomized study.

He et al. 2016Fertility and sterilitycited by 29

PMID 27143518DOI 10.1016/j.fertnstert.2016.04.019PUB-27143518

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2014

A randomized double blind comparison of atosiban in patients undergoing IVF treatment.

Ng et al. 2014Human reproduction (Oxford, England)cited by 38

PMID 25336707DOI 10.1093/humrep/deu263PUB-25336707

Rights unknown
Source link

PubMed tag: none · 2013

[Application of oxytocin antagonists in thaw embryo transfer].

Song et al. 2013Zhonghua fu chan ke za zhicited by 8

PMID 24332133PUB-24332133

Full text at the publisher
Publisher page

PubMed tag: none · 2011

Use of an oxytocin antagonist in in vitro fertilization-embryo transfer for women with repeated implantation failure: a retrospective study.

Chou et al. 2011Taiwanese journal of obstetrics & gynecologycited by 25

PMID 21791296DOI 10.1016/j.tjog.2011.04.003PUB-21791296

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2010

Treatment with oxytocin antagonists before embryo transfer may increase implantation rates after IVF.

Moraloglu et al. 2010Reproductive biomedicine onlinecited by 48

PMID 20638340DOI 10.1016/j.rbmo.2010.04.009PUB-20638340

Full text at the publisher
Publisher page

Indexing hint: In vitro study · 2004

Oxytocin receptor gene expression of estrogen-stimulated human myometrium in extracorporeally perfused non-pregnant uteri.

Richter et al. 2004Molecular human reproductioncited by 50

PMID 15044599DOI 10.1093/molehr/gah039PUB-15044599

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2000

An oxytocin receptor antagonist (atosiban) in the treatment of preterm labor: a randomized, double-blind, placebo-controlled trial with tocolytic rescue.

Romero et al. 2000American journal of obstetrics and gynecologycited by 179

PMID 10819855DOI 10.1067/mob.2000.95834PUB-10819855

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultCoughlan C, Ledger W, Wang Q, Liu F, Demirol A, Gurgan T, Cutting R, Ong K, Sallam H, Li TC. Recurrent implantation failure: definition and management. Reprod Biomed Online. 2014 Jan;28(1):14-38. doi: 10.1016/j.rbmo.2013.08.011. Epub 2013 Sep 14. PMID 24269084
  • ResultSimon A, Laufer N. Repeated implantation failure: clinical approach. Fertil Steril. 2012 May;97(5):1039-43. doi: 10.1016/j.fertnstert.2012.03.010. Epub 2012 Mar 30. PMID 22464086
  • ResultMargalioth EJ, Ben-Chetrit A, Gal M, Eldar-Geva T. Investigation and treatment of repeated implantation failure following IVF-ET. Hum Reprod. 2006 Dec;21(12):3036-43. doi: 10.1093/humrep/del305. Epub 2006 Aug 12. PMID 16905766
  • ResultKnutzen V, Stratton CJ, Sher G, McNamee PI, Huang TT, Soto-Albors C. Mock embryo transfer in early luteal phase, the cycle before in vitro fertilization and embryo transfer: a descriptive study. Fertil Steril. 1992 Jan;57(1):156-62. PMID 1730311
  • ResultFanchin 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 9740459
  • ResultLesny P, Killick SR, Robinson J, Raven G, Maguiness SD. Junctional zone contractions and embryo transfer: is it safe to use a tenaculum? Hum Reprod. 1999 Sep;14(9):2367-70. doi: 10.1093/humrep/14.9.2367. PMID 10469712
  • ResultZhu L, Li Y, Xu A. Influence of controlled ovarian hyperstimulation on uterine peristalsis in infertile women. Hum Reprod. 2012 Sep;27(9):2684-9. doi: 10.1093/humrep/des257. Epub 2012 Jul 14. PMID 22798632
  • ResultAyoubi 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 12738502
  • ResultLan VT, Khang VN, Nhu GH, Tuong HM. Atosiban improves implantation and pregnancy rates in patients with repeated implantation failure. Reprod Biomed Online. 2012 Sep;25(3):254-60. doi: 10.1016/j.rbmo.2012.05.014. Epub 2012 Jun 16. PMID 22818095
  • ResultZhang Yue, Zhu Yujing, Luo Haining, et al. Clinical observation on the effect of the patients using Atosiban for frozen thawed embryo transfer after repeated failure of implantation. Chinese Journal of Family Planning,2016,22 (05): 325-328.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 3 or more than 3 embryo implantation failure histories previously (or the number of high-quality embryos transplanted is \>4); 2. Age \<40 years； 3. Ultrasound or HSG showed normal uterine cavity, endometrium on transplantation day is ≥ 8mm; 4. There's at least one good quality embryo on transplantation day. Exclusion Criteria: 1. Patients using donor sperm or donor eggs; 2. Patients have obvious uterine cavity abnormalities; 3. There was a clear hydrosalpinx; 4. Natural cycles or IVM patients; 5. Patients who cancel the due to the transfer due to various reasons, such as the failure of fertilization, or ovarian transitional stimulus syndrome (OHSS); 6. Abnormal karyotype; 7. Blastocyst transplantation patients.

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