Current partner codePEPTIDESDE
NCT03904745·Not applicable·INTERVENTIONAL

Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer

Status

Unknown

Phase

Not applicable

Enrollment

250

Locations

2

Results

Not posted

Publications

6

Study summary

What the protocol is testing.

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.

Full detailed description

Inhibition of uterine contractions in order to increase implantation rates have been studied on several agents in the last two decades. Beta-adrenergic agonists and non-steroidal anti-inflammatory drugs have been shown to have no benefit on implantation rates. Vasopressin V1a and oxytocin receptor antagonist atosiban was first studied on premature labor patients and found to be effective. 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.

Interventions

Treatment arms and agents.

DRUG

Atosiban

6,75mg of atosiban will be administered intravenously 30 minutes before embryo transfer

Timeline

From registration to results.

  1. First posted

    Apr 5, 2019

  2. Study start

    Dec 21, 2020

  3. Primary completion

    Jul 30, 2021

  4. Study completion

    Dec 30, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Dec 16, 2020

Outcomes

What the study measures.

Primary outcomes

Pregnancy rates

Time frame · 1 year

Pregnancy rates of the participants

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations

2 registered sites.

Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.

Bezmialem University

Istanbul, Turkey (Türkiye)

Yeditepe University

Istanbul, Turkey (Türkiye)

Publications

Results and literature.

PMID 7802081Bossmar 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 30158812Mishra 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 1313946Kimura 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 9740459Fanchin 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 22818095Lan 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 34467530Craciunas 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.

Primary links

Continue at the source.

Related trials

More studies on Atosiban.

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