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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03904745
• Other study ID #: Atosiban study
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2020
• Source: Bezmialem Vakif University
• Contact: Pinar Ozcan
• Phone: +905414031625
• Email: pinarozcan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Atosiban
6,75mg of atosiban will be administered intravenously 30 minutes before embryo transfer

Locations

Country	Name	City	State
Turkey	Bezmialem University	Istanbul
Turkey	Yeditepe University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Bezmialem Vakif University	Yeditepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Erratum in: Nature 1992 May 14;357(6374):176. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rates	Pregnancy rates of the participants	1 year