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

NCT ID: NCT03381001

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2019-08-10

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

embryo transfer after embryo thaw

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

Group Type: ACTIVE_COMPARATOR

embryo transfer with no culture

Intervention Type: PROCEDURE

embryos will be transfer with no culture after thaw

embryo transfer after thaw and culture

Embryos will be transferred one day after thawing procedure

Group Type: EXPERIMENTAL

embryo transfer after thaw and culture

Intervention Type: PROCEDURE

embryos will be kept in culture after thawing for one day before transfer for the uterus

Interventions

embryo transfer after thaw and culture

embryos will be kept in culture after thawing for one day before transfer for the uterus

Intervention Type: PROCEDURE

embryo transfer with no culture

embryos will be transfer with no culture after thaw

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Selmo Geber

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

selmo Geber, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 23040524 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27203090 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25747130 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27817036 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28333033 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32533985 (View on PubMed)

Other Identifiers

TEC+1

Identifier Type: -

Identifier Source: org_study_id