Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
NCT ID: NCT03904745
Last Updated: 2020-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2020-12-21
2021-12-30
Brief Summary
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Detailed Description
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Endometrium-originated oxytocin can possibly stimulate myometrium and have a negative impact on embryo implantation. Inhibition of oxytocin receptors has been shown to reduce uterine contraction frequency in non-pregnant women. Atosiban has been studied on assisted reproductive technologies in the last decade and has been shown to be effective on increasing implantation and clinical pregnancy rates. However, previous studies have used a 37,5 mg total dose of atosiban which was used both before and during embryo transfer. We aim to use a single and low dose of 6,75mg atosiban only before embryo transfer, which is simpler and cheaper and the medication given to patient is significantly lower. If we can demostrate the positive effect of our protocol, it can be suggested to be used routinely in all in vitro fertilization cycles. Additionally, our study is an original study in terms of being the first randomized clinical trial studying the effect of atosiban on frozen-thawed embryo transfer cycles.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Atosiban used before embryo transfer
the patients in this group will be administered 6,75mg atosiban intravenously.
Atosiban
6,75mg of atosiban will be administered intravenously 30 minutes before embryo transfer
Control group
the patients in this group will not be administered atosiban before embryo transfer.
No interventions assigned to this group
Interventions
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Atosiban
6,75mg of atosiban will be administered intravenously 30 minutes before embryo transfer
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Yeditepe University
OTHER
Bezmialem Vakif University
OTHER
Responsible Party
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Locations
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Bezmialem University
Istanbul, , Turkey (Türkiye)
Yeditepe University
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Pinar Ozcan
Role: primary
Mert Yesiladali
Role: primary
References
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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.
Mishra 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.
Kimura 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.
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.
Lan 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.
Craciunas 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.
Other Identifiers
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Atosiban study
Identifier Type: -
Identifier Source: org_study_id