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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: embryo transfer after thaw and culture; Procedure: embryo transfer with no culture

• Registration Number: NCT03381001
• Lead Sponsor: Federal University of Minas Gerais

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-15
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Primary Completion: 2019-06-15
• Status Verified: 2019-08
• Study Completion: 2019-08-10
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
embryo transfer after thaw and culture	embryo transfer after thaw and culture	Embryos will be transferred one day after thawing procedure
embryo transfer after embryo thaw	embryo transfer with no culture	Embryos will be transferred at the same day of the thawing procedure

Primary Outcome Measures

Name	Time	Method
pregnancy rates	8 weeks	percentage of patients that become pregnant after Frozen embryo transfer

Secondary Outcome Measures

Name	Time	Method
implantation rate	6 weeks	percentage of gestational sac according to the number of transferred embryos
embryo development	24 hours	percentage of embryos that develop after thawing and before transfer

Trial Locations

Locations (1)

Hospital das Clinicas - Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil