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

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03904745
Collaborator
Yeditepe University (Other)
250
2
2
12.3
125
10.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
Anticipated Study Start Date :
Dec 21, 2020
Anticipated Primary Completion Date :
Jul 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atosiban used before embryo transfer

the patients in this group will be administered 6,75mg atosiban intravenously.

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

No Intervention: Control group

the patients in this group will not be administered atosiban before embryo transfer.

Outcome Measures

Primary Outcome Measures

  1. Pregnancy rates [1 year]

    Pregnancy rates of the participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem University Istanbul Turkey 34746
2 Yeditepe University Istanbul Turkey 34746

Sponsors and Collaborators

  • Bezmialem Vakif University
  • Yeditepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT03904745
Other Study ID Numbers:
  • Atosiban study
First Posted:
Apr 5, 2019
Last Update Posted:
Dec 16, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2020