Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Atosiban
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring in vitro fertilization, atosiban, embryo transfer, oxytocin antagonist
Eligibility Criteria
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
Sites / Locations
- Bezmialem UniversityRecruiting
- Yeditepe UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Atosiban used before embryo transfer
Control group
Arm Description
the patients in this group will be administered 6,75mg atosiban intravenously.
the patients in this group will not be administered atosiban before embryo transfer.
Outcomes
Primary Outcome Measures
Pregnancy rates
Pregnancy rates of the participants
Secondary Outcome Measures
Full Information
NCT ID
NCT03904745
First Posted
April 4, 2019
Last Updated
December 13, 2020
Sponsor
Bezmialem Vakif University
Collaborators
Yeditepe University
1. Study Identification
Unique Protocol Identification Number
NCT03904745
Brief Title
Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
Official Title
Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2020 (Anticipated)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
Collaborators
Yeditepe University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
in vitro fertilization, atosiban, embryo transfer, oxytocin antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atosiban used before embryo transfer
Arm Type
Experimental
Arm Description
the patients in this group will be administered 6,75mg atosiban intravenously.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
the patients in this group will not be administered atosiban before embryo transfer.
Intervention Type
Drug
Intervention Name(s)
Atosiban
Intervention Description
6,75mg of atosiban will be administered intravenously 30 minutes before embryo transfer
Primary Outcome Measure Information:
Title
Pregnancy rates
Description
Pregnancy rates of the participants
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pinar Ozcan
Phone
+905414031625
Email
pinarozcan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Taha Takmaz
Phone
+905548707340
Email
thtkmz@hotmail.com
Facility Information:
Facility Name
Bezmialem University
City
Istanbul
ZIP/Postal Code
34746
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinar Ozcan
Facility Name
Yeditepe University
City
Istanbul
ZIP/Postal Code
34746
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mert Yesiladali
Phone
+905321000206
Email
yesiladali@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
7802081
Citation
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.
Results Reference
background
PubMed Identifier
30158812
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.
Results Reference
background
PubMed Identifier
1313946
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. doi: 10.1038/356526a0. Erratum In: Nature 1992 May 14;357(6374):176.
Results Reference
background
PubMed Identifier
9740459
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. doi: 10.1093/humrep/13.7.1968.
Results Reference
background
PubMed Identifier
22818095
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.
Results Reference
background
PubMed Identifier
34467530
Citation
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.
Results Reference
derived
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Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
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