Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
1 other identifier
interventional
250
1 country
2
Brief Summary
Uterine contraction has a negative impact on implantation and pregnancy rates. Inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. Atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. Previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. We aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. Our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedStudy Start
First participant enrolled
December 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedDecember 16, 2020
December 1, 2020
7 months
April 4, 2019
December 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy rates
Pregnancy rates of the participants
1 year
Study Arms (2)
Atosiban used before embryo transfer
EXPERIMENTALthe patients in this group will be administered 6,75mg atosiban intravenously.
Control group
NO INTERVENTIONthe patients in this group will not be administered atosiban before embryo transfer.
Interventions
6,75mg of atosiban will be administered intravenously 30 minutes before embryo transfer
Eligibility Criteria
You may qualify if:
- Infertile women applied to assisted reproduction clinic
- Follicle stimulating hormone \< 12
- Body mass index \< 25
- Patients whom antagonist protocol will be used
- Patients whom at least 2 good-quality embryos obtained
- Patients who are volunteer
You may not qualify if:
- Severe male factor (Sperm concentration \<5 M/ml, progressive sperm motility \<%10)
- Uterine anomaly
- Hydrosalphynx
- Difficult embryo transfer
- Patients who previously had a diagnosis of endometriosis and / or adenomyosis
- Endocrine problems (hypothyroidism, hyperthyroidism, hyperprolactinemia, premature ovarian insufficiency)
- Having more than 3 in vitro fertilization failure
- Refusing to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bezmialem Vakif Universitylead
- Yeditepe Universitycollaborator
Study Sites (2)
Bezmialem University
Istanbul, 34746, Turkey (Türkiye)
Yeditepe University
Istanbul, 34746, Turkey (Türkiye)
Related Publications (6)
Bossmar T, Akerlund M, Fantoni G, Szamatowicz J, Melin P, Maggi M. Receptors for and myometrial responses to oxytocin and vasopressin in preterm and term human pregnancy: effects of the oxytocin antagonist atosiban. Am J Obstet Gynecol. 1994 Dec;171(6):1634-42. doi: 10.1016/0002-9378(94)90415-4.
PMID: 7802081BACKGROUNDMishra V, Agarwal H, Goel S, Roy P, Choudhary S, Lamba S. A Prospective Case-control Trial to Evaluate and Compare the Efficacy and Safety of Atosiban versus Placebo in In vitro Fertilization-embryo Transfer Program. J Hum Reprod Sci. 2018 Apr-Jun;11(2):155-160. doi: 10.4103/jhrs.JHRS_7_17.
PMID: 30158812BACKGROUNDKimura T, Tanizawa O, Mori K, Brownstein MJ, Okayama H. Structure and expression of a human oxytocin receptor. Nature. 1992 Apr 9;356(6369):526-9. doi: 10.1038/356526a0.
PMID: 1313946BACKGROUNDFanchin 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: 9740459BACKGROUNDLan 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: 22818095BACKGROUNDCraciunas L, Tsampras N, Kollmann M, Raine-Fenning N, Choudhary M. Oxytocin antagonists for assisted reproduction. Cochrane Database Syst Rev. 2021 Sep 1;9(9):CD012375. doi: 10.1002/14651858.CD012375.pub2.
PMID: 34467530DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 5, 2019
Study Start
December 21, 2020
Primary Completion
July 30, 2021
Study Completion
December 30, 2021
Last Updated
December 16, 2020
Record last verified: 2020-12