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UnknownNCT03904745

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
250 (estimated)
Sponsor
Bezmialem Vakif University · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGAtosiban6,75mg of atosiban will be administered intravenously 30 minutes before embryo transfer

Timeline

Start date
2020-12-21
Primary completion
2021-07-30
Completion
2021-12-30
First posted
2019-04-05
Last updated
2020-12-16

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03904745. Inclusion in this directory is not an endorsement.