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

NCT03381001 | Completed DMC

• 1 other identifier: TEC+1
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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

Keywords

cryopreservation; human embryos; vitrification; embryo culture; embryo transfer; pregnancy rate

Outcome Measures

Primary Outcomes (1)

• pregnancy rates

  percentage of patients that become pregnant after Frozen embryo transfer

  8 weeks

Secondary Outcomes (2)

• implantation rate

  6 weeks

• embryo development

  24 hours

Study Arms (2)

embryo transfer after embryo thaw

ACTIVE COMPARATOR

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

Procedure: embryo transfer with no culture

embryo transfer after thaw and culture

EXPERIMENTAL

Embryos will be transferred one day after thawing procedure

Procedure: embryo transfer after thaw and culture

Interventions

embryo transfer after thaw and culture PROCEDURE

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

embryo transfer after thaw and culture

embryo transfer with no culture PROCEDURE

embryos will be transfer with no culture after thaw

embryo transfer after embryo thaw

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: only women can have an embryo transfer
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients submitted to ART treatment due to infertility that had frozen embryos and need an embryo transfer after endometrial preparation and embryo thawing

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

Related Publications (6)

• 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.

  PMID: 23040524 RESULT

• 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.

  PMID: 27203090 RESULT

• 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.

  PMID: 25747130 RESULT

• 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.

  PMID: 27817036 RESULT

• 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.

  PMID: 28333033 RESULT

• 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.

  PMID: 32533985 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Culture Techniques; Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics

Study Officials

• selmo Geber, MD PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective, randomized, triple-blinded study

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 21, 2017
• Study Start: June 15, 2017
• Primary Completion: June 15, 2019
• Study Completion: August 10, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)