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Influence of Post-thaw Embryo Culture Interval on Assisted Reproduction Success Rates

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
embryo transfer after thaw and culture
embryo transfer with no culture
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring cryopreservation, human embryos, vitrification, embryo culture, embryo transfer, pregnancy rate

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patients submitted to ART treatment due to infertility that had frozen embryos and need an embryo transfer after endometrial preparation and embryo thawing

Exclusion Criteria:

  • patients that does not reach criteria for frozen embryo transfer (thin endometrium, bleeding, inappropriate use of hormones)
  • difficult embryo transfer
  • embryos that were frozen twice

Sites / Locations

  • Hospital das Clinicas - Universidade Federal de Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

embryo transfer after embryo thaw

embryo transfer after thaw and culture

Arm Description

Embryos will be transferred at the same day of the thawing procedure

Embryos will be transferred one day after thawing procedure

Outcomes

Primary Outcome Measures

pregnancy rates
percentage of patients that become pregnant after Frozen embryo transfer

Secondary Outcome Measures

implantation rate
percentage of gestational sac according to the number of transferred embryos
embryo development
percentage of embryos that develop after thawing and before transfer

Full Information

First Posted
December 11, 2017
Last Updated
August 13, 2019
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT03381001
Brief Title
Influence of Post-thaw Embryo Culture Interval on Assisted Reproduction Success Rates
Official Title
Influence of Post-thaw Embryo Culture Interval Before Embryo Transfer on Assisted Reproduction Success Rates
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
August 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The transfer of frozen / thawed embryos has been routinely performed in the last 30 years as part of Assisted Reproduction treatment (ART). Currently, more than 50% of couples submitted to ART have surplus embryos eligible for freezing followed by transfer in subsequent cycles. Therefore the selection criteria for the thawed embryos to be transferred must be rigorous in order to maximize pregnancy and of live birth rates. Usually, the evaluation of the embryos before transfer can be performed based on blastomeres survival after a short culture period between thaw and embryos transfer, i.e., 2 to 5 hours, or based on embryo development over a prolonged period of culture (18h to 24h). Post-thaw embryo culture might have an impact on the recovery of mitosis and normal cellular functions. However, until now, there is no consensus in the literature on which post-thaw culture interval has a better impact on pregnancy and live birth rates. Also, blastocysts formation after freezing/thawing of embryos at cleavage stage may bring relevant information about post-thaw culture. Moreover, this strategy can be used as an alternative treatment. Therefore, the authors proposed this prospective randomized, triple-blind study to evaluate the impact of post-thaw embryo culture on the pregnancy and live birth rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
cryopreservation, human embryos, vitrification, embryo culture, embryo transfer, pregnancy rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, triple-blinded study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
embryo transfer after embryo thaw
Arm Type
Active Comparator
Arm Description
Embryos will be transferred at the same day of the thawing procedure
Arm Title
embryo transfer after thaw and culture
Arm Type
Experimental
Arm Description
Embryos will be transferred one day after thawing procedure
Intervention Type
Procedure
Intervention Name(s)
embryo transfer after thaw and culture
Intervention Description
embryos will be kept in culture after thawing for one day before transfer for the uterus
Intervention Type
Procedure
Intervention Name(s)
embryo transfer with no culture
Intervention Description
embryos will be transfer with no culture after thaw
Primary Outcome Measure Information:
Title
pregnancy rates
Description
percentage of patients that become pregnant after Frozen embryo transfer
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
implantation rate
Description
percentage of gestational sac according to the number of transferred embryos
Time Frame
6 weeks
Title
embryo development
Description
percentage of embryos that develop after thawing and before transfer
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women can have an embryo transfer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients submitted to ART treatment due to infertility that had frozen embryos and need an embryo transfer after endometrial preparation and embryo thawing Exclusion Criteria: patients that does not reach criteria for frozen embryo transfer (thin endometrium, bleeding, inappropriate use of hormones) difficult embryo transfer embryos that were frozen twice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
selmo Geber, MD PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas - Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130100
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
we don't have permission to share participant data
Citations:
PubMed Identifier
23040524
Citation
Roque M, Lattes K, Serra S, Sola I, Geber S, Carreras R, Checa MA. Fresh embryo transfer versus frozen embryo transfer in in vitro fertilization cycles: a systematic review and meta-analysis. Fertil Steril. 2013 Jan;99(1):156-162. doi: 10.1016/j.fertnstert.2012.09.003. Epub 2012 Oct 3.
Results Reference
result
PubMed Identifier
27203090
Citation
Roque M, Valle M, Guimaraes F, Sampaio M, Geber S. Cost-Effectiveness of the Freeze-All Policy. JBRA Assist Reprod. 2015 Aug 1;19(3):125-30. doi: 10.5935/1518-0557.20150028.
Results Reference
result
PubMed Identifier
25747130
Citation
Roque M, Valle M, Guimaraes F, Sampaio M, Geber S. Freeze-all policy: fresh vs. frozen-thawed embryo transfer. Fertil Steril. 2015 May;103(5):1190-3. doi: 10.1016/j.fertnstert.2015.01.045. Epub 2015 Mar 4.
Results Reference
result
PubMed Identifier
27817036
Citation
Roque M, Valle M, Guimaraes F, Sampaio M, Geber S. Freeze-all cycle for all normal responders? J Assist Reprod Genet. 2017 Feb;34(2):179-185. doi: 10.1007/s10815-016-0834-x. Epub 2016 Nov 5.
Results Reference
result
PubMed Identifier
28333033
Citation
Roque M, Valle M, Kostolias A, Sampaio M, Geber S. Freeze-all cycle in reproductive medicine: current perspectives. JBRA Assist Reprod. 2017 Feb 1;21(1):49-53. doi: 10.5935/1518-0557.20170012.
Results Reference
result
PubMed Identifier
32533985
Citation
Colodetti L, Pinho de Franca P, Sampaio M, Geber S. Do different culture intervals (2 x 24 hours) after thaw of cleavage stage embryos affect pregnancy rates? A randomized controlled trial. Cryobiology. 2020 Aug;95:80-83. doi: 10.1016/j.cryobiol.2020.06.002. Epub 2020 Jun 10.
Results Reference
derived

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Influence of Post-thaw Embryo Culture Interval on Assisted Reproduction Success Rates

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