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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381001
• Other study ID #: TEC+1
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: August 10, 2019

Study information

• Verified date: August 2019
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: August 10, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• embryo transfer after thaw and culture
embryos will be kept in culture after thawing for one day before transfer for the uterus
• embryo transfer with no culture
embryos will be transfer with no culture after thaw

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Roque M, Lattes K, Serra S, Solà 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):156-62. doi: 10.1016/j.fertnstert — View Citation

Roque M, Valle M, Guimarães 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. — View Citation

Roque M, Valle M, Guimarães 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. — View Citation

Roque M, Valle M, Guimarães 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rates	percentage of patients that become pregnant after Frozen embryo transfer	8 weeks
Secondary	implantation rate	percentage of gestational sac according to the number of transferred embryos	6 weeks
Secondary	embryo development	percentage of embryos that develop after thawing and before transfer	24 hours