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

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Post-thaw Embryo Culture Interval Before Embryo Transfer on Assisted Reproduction Success Rates

Conditions
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Infertility

Intervention / Treatment
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* Procedure: embryo transfer after thaw and culture
* Procedure: embryo transfer with no culture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, triple-blinded study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: embryo transfer after embryo thaw<br>Embryos will be transferred at the same day of the thawing procedure | Procedure: embryo transfer with no culture<br>* embryos will be transfer with no culture after thaw<br>|
| Experimental: embryo transfer after thaw and culture<br>Embryos will be transferred one day after thawing procedure | Procedure: embryo transfer after thaw and culture<br>* embryos will be kept in culture after thawing for one day before transfer for the uterus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rates | percentage of patients that become pregnant after Frozen embryo transfer | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | percentage of gestational sac according to the number of transferred embryos | 6 weeks | 
| embryo development | percentage of embryos that develop after thawing and before transfer | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryopreservation, human embryos, vitrification, embryo culture, embryo transfer, pregnancy rate