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

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ClinicalTrials.gov Identifier: NCT03381001
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: embryo transfer after thaw and culture Procedure: embryo transfer with no culture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, triple-blinded study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Post-thaw Embryo Culture Interval Before Embryo Transfer on Assisted Reproduction Success Rates
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : June 15, 2019
Actual Study Completion Date : August 10, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: embryo transfer after embryo thaw
Embryos will be transferred at the same day of the thawing procedure
 Procedure: embryo transfer with no culture
embryos will be transfer with no culture after thaw
Experimental: embryo transfer after thaw and culture
Embryos will be transferred one day after thawing procedure
 Procedure: embryo transfer after thaw and culture
embryos will be kept in culture after thawing for one day before transfer for the uterus


Outcome Measures
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Primary Outcome Measures :
  1. pregnancy rates [ Time Frame: 8 weeks ]
    percentage of patients that become pregnant after Frozen embryo transfer


Secondary Outcome Measures :
  1. implantation rate [ Time Frame: 6 weeks ]
    percentage of gestational sac according to the number of transferred embryos

  2. embryo development [ Time Frame: 24 hours ]
    percentage of embryos that develop after thawing and before transfer


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only women can have an embryo transfer
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381001


Locations
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Brazil
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Principal Investigator: selmo Geber, MD PhD Federal University of Minas Gerais
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Selmo Geber, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03381001    
Other Study ID Numbers: TEC+1
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we don't have permission to share participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Selmo Geber, Federal University of Minas Gerais:
cryopreservation
human embryos
vitrification
 embryo culture
embryo transfer
pregnancy rate
Additional relevant MeSH terms:
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Infertility